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Regulatory Issues

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		827--POROUS COATING GUIDANCE ^Votes:0 FDA Home Page \| CDRH Home Page \| Search \| CDRH A-Z Index \| Contact CDRH Guidance Document For Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's April 28, 1994 Orthopedic Devices Branch Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health U.S. Food and Drug Ad Read More Go to Site


		ASTM F1408-97(2002)e1 Standard Practice for Subcutaneous Screening Test for Implant Materials ^Votes:0 Order Now: (Credit Card Only) ACTIVE STANDARD: Pages: 5 Price: $ 35.00 Choose delivery method: Download (PDF) Mail Delivery What is an Active standard? HISTORICAL STANDARD: View Previous Versions of this Standard What is an Historical Standard? Help Desk Document Summary Copyright 2007 ASTM International. All rights reserved. ACTIVE STANDARD: ASTM F1408-97(2002)e1 Standard Practice for Subcutaneous Screening Test for Implant Materials Developed by Subcommittee: F04.16 See Related Work by this Subcommittee Adoptions: Book of Standards Volume: 13.01 1. Scope 1.1 This practice covers a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant candidate materials in small laboratory animals. The material may be dense or porous. The tissue reactions will Read More Go to Site

		BrÅnemark Implant® Abstracts ^Votes:0 Nobel Biocare/University of Michigan Center For Excellence BrÅnemark Implant® Abstracts New Finite Element Analysis at the Implant/Bone Interface for One-Piece vs Multi-Unit Implant Systems An Auger Spectroscopic Analysis of Dental Implant Surface Contamination Examination of the Implant-Abutment Interface After Fatigue Testing Finite Element Analysis at the Implant/Bone Interface for One-Piece vs Multi-Unit Implant Systems Wang R-F, Kang B, and Lang BR. Finite element analysis at the implant/bone interface for one-piece versus multi-unit implant systems. [Abstract # 2416] J Dent Res 2003;82:B-312. Abstract: The recent introduction of implant systems that combine the implant and the abutment as one unit has prompted the question of whether or not these new systems result in dif Read More Go to Site

		Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments; Guidance for Industry and FDA ^Votes:0 FDA Home Page \| CDRH Home Page \| Search \| A-Z Index Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments Document issued on : May 12, 2004 The draft of this document was issued on May 14, 2002 This document supersedes: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA issued May 14, 2002 Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; Final, 04/21/1999 Information Necessary for Premarket Notification Submissions For Screw-Type Endosseous Implants, 12/09/1996 Guidance For the Arrangement and Content of a Premarket Approval (PMA) Application for An Endosseous Implan Read More Go to Site

		F2026-00 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications ^Votes:0 Order Now: (Credit Card Only) DOWNLOAD THIS HISTORICAL STANDARD: Download (PDF) Price: $ 36.00 Pages: 4 What is an Historical standard? VIEW OTHER STANDARDS Active Standard Other Historical Standards Help Desk Document Summary Copyright 2007 ASTM International. All rights reserved. HISTORICAL STANDARD: F2026-00 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications SUPERSEDED 1. Scope 1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. 1.2 As with Read More Go to Site

		F67-00 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) ^Votes:0 Volume 13.01, Issued September 2000 F67-00 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) Copyright © 2000 AMERICAN SOCIETY FOR TESTING AND MATERIALS, West Conshohocken, PA. All rights reserved. Use of this CD-ROM is subject to a license from ASTM. Click to view license. Scroll down to view scope Return to Search page Return to Standards by Section and Volume Return to Standards by Technical Committee 1. Scope 1.1 This specification covers the chemical, mechanical, and metallurgical requirements for four grades of unalloyed titanium used for the manufacture of surgical implants. 1.2 The values stated in inch-pound units are to be regarded as the standard. Subject Index metals (for surgical implants); orthopae Read More Go to Site

		FDA > CDRH > CFR Title 21 Database Search ^Votes:0 FDA Home Page \| CDRH Home Page \| Search \| A-Z Index 510(k) \| Registration \| Listing \| Adverse Events \| PMA \| Classification \| CLIA CFR Title 21 \| Advisory Committees \| Assembler \| Recalls \| Guidance \| Standards New Search Help \| More About 21CFR [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2006] [CITE: 21CFR872.3580] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 872 -- DENTAL DEVICES Subpart D--Prosthetic Devices Sec. 872.3580 Preformed gold denture tooth. (a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion Read More Go to Site

		http://www.isds.org/LawsLegislation/RegulatoryIssues/PIMWD/Statute.pdf ^Votes:0 PDF Document Read More Go to Site

		Implant Dentistry - userLogin ^Votes:0 This site is scheduled to undergo maintenance on Saturday, August 11 from 5:00pm-10:00pm EST (10:00pm-3:00am GMT). During this period, the site and its contents may be unavailable. Thank you for your patience as this work is being performed. --> Due to scheduled system maintenance on Monday, September 10 th , between the hours of 4:00 PM EDT and 8:00 PM EDT (20:00 - 24:00 GMT), you may experience service interruptions on this site. We apologize for any inconvenience this may cause; if you have any questions, please use the Support link provided on this page. --> LWWOnline \| LOGIN \| eALERTS \| REGISTER \| CUSTOMER SUPPORT Home Search Current Issue Archive ADVERTISEMENT You are attempting to access protected content. To access this content please login using an established account or create/ac Read More Go to Site

		ISDS: ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend RPZ Valves RPZ valve requirements can be met by reviewing the following guidelines. Local municipalities may require more then these state guidelines so please check with your local government office. Illinois Department of Public Health, Office of Health Protection General Inquiries: 217/782-4977 Office of Health Protection: 217/782-3984 Plumbing Program Policy #13 This policy addresses the Illinois Department of Public Health general responsibilities and regulations regarding protection of the potable water supply pertaining to dental offices and clinics. The Department is charged with the oversight of the safety of these facilities, and with the construction, maintenance, code of Read More Go to Site

		ISDS: Advertising ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > Advertising Advertising Advertising by dentists is regulated by the State of Illinois. The following excerpts from the regulations will help you when deciding how to name your practice or advertise your services. Persons licensed to practice dentistry in the State of Illinois may advertise in any medium or other form of public communications in a manner which is truthful, and which is not fraudulent, deceptive, inherently misleading or proven to be misleading in practice. Such advertising shall contain all information necessary to make the communication not misleading and shall not contain any false or misleading statement or otherwis Read More Go to Site

		ISDS: Anesthesia permits ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > Licenses and Permits > Anesthesia permits Anesthesia Permits According to the Illinois Dental Practice Act, licensed dentists who wish to provide conscious sedation or deep and general anesthesia services to patients must first obtain an anesthesia permit from the Illinois Department of Professional Regulation. Depending on the level of service to be provided, the dentist must apply for either a Permit A or Permit B. Neither permit is required if the dentist is merely providing an oral medication or nitrous oxide analgesia to reduce anxiety. Permit A This permit is required if a dentist wishes to provide conscious sedation regardless Read More Go to Site

		ISDS: Illinois Dental Practice Act ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > Licenses and Permits > Illinois Dental Practice Act Illinois Dental Practice Act Licenses and permits to practice dentistry and dental hygiene or to prescribe medication for a patient must be obtained by a dentist or dental hygienist on forms provided by the Department of Professional Regulation. A summary of these licenses and fees is presented below. Illinois Dental Practice Act (225 ILCS 25/11) Sec. 11. Types of Dental Licenses. The Department shall have the authority to issue the following types of licenses: a. General licenses. The Department shall issue a license authorizing practice as a dentist to any person who qualifies for Read More Go to Site

		ISDS: License to Practice Dentistry or Dental Hygiene ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > Licenses and Permits > License to Practice Dentistry or Dental Hygiene License to Practice Dentistry or Dental Hygiene Dentistry The Illinois Department of Professional Regulation (IDPR) is the state agency charged with issuing a license to practice dentistry in the state. Any dentist wishing to practice must first obtain a general license which permits the dentist to practice in all areas of dentistry. Following post-graduate study in a specialty area, a dentist may apply and be tested for a specialty license in the areas of orthodontics, pediatric dentistry, oral & maxillofacial surgery, periodontics, prosthodontics, or endodontics. Read More Go to Site

		ISDS: Prescription writing authority ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > Licenses and Permits > Prescription writing authority Prescription Writing Authority Licensed dentists in Illinois may write prescriptions only in connection with dental-related ailments or conditions. To write a prescription for any other non-dental condition is a violation of the Illinois Dental Practice Act and may make the dentist liable for license sanction. By virtue of receiving the general dental license, a dentist may write prescriptions for non-controlled substances. However, if a dentist wishes to have the authority to prescribe for controlled substances as defined by the U.S. Drug Enforcement Administration (DEA) , then he Read More Go to Site

		ISDS: Special Requirements for Small Generators of PIMW ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > Potentially Infectious Medical Waste Disposal > Special Requirements for Small Generators of PIMW Special Requirements for Small Generators of Potential Infectious Medical Waste (PIMW) In order to improve the management of medical waste, the Illinois Environmental Protection Act was amended by adding Title XV (Public Act 87-752, House Bill 2491). This Title establishes statutory and regulatory requirements to ensure that Potentially Infectious Medical Waste (?PIMW?) will be handled in a safe and responsible manner. PIMW has replaced the term Hazardous (Infectious) Hospital Waste in the Illinois Environmental Protection Act and related Read More Go to Site

		ISDS: X-Ray Equipment Registration ^Votes:0 Illinois State Dental Society Home Member Login Contact ISDS Site Search Printer Friendly Email To A Friend Home > Laws and Legislation > Regulatory Issues > X-Ray Equipment Registration X-Ray Equipment Registration Every dentist who operates an x-ray machine must register with the Department of Nuclear Safety on an annual basis. If you have questions on x-ray fees or inspections, contact the Department at 217/785-9918. Every operator of a radiation installation must register radiation machines annually on a form prescribed by the Department. An annual registration fee for each machine possessed on January 1 of each year must be submitted with the registration form. The registration fee for calendar years 2003 and 2004 for Class A facility type (dental and veterinary offices) is $35 per ra Read More Go to Site

		Job Accommodation Network ^Votes:0 Job Accommodation Network &nbsp&nbsp&nbsp&nbsp &nbsp&nbsp&nbsp&nbsp &nbsp&nbsp&nbsp&nbsp &nbsp &nbsp &nbsp &nbsp &nbsp ADA Questions and Answers This information has been compiled to assist the general public in understanding and complying with the Americans with Disabilities Act. It does not constitute a determination by the Department of Justice of your rights and responsibilities, and it is not binding on the Department. Introduction Barriers to employment, transportation, public accommodations, public services, and telecommunications have imposed staggering economic and social costs on American society and have undermined our well-intentioned efforts to educate, rehabilitate, and employ individuals with disabilities. By breaking down these barriers, the Americans with Disabilities Act Read More Go to Site

		The TMJ Association, Ltd. Changing The Face of TMJ ^Votes:0 Home \| Ask the TMJA \| Site Map What's New Shop On-line for the Holidays & Support The TMJA! Research Grant Opportunities You Are the Face of TMJ Splint & Bruxism Study Released TMJ Implant GAO Report Released Natural TMJ Disc The TMJA - Giving TMJ Patients A Voice Archives My Profile Update Profile Forgot Password? Register Who We Are - Member Presentations Biomaterials and Medical Devices: An Industry in Transition The Impact of Healthcare Reform, Product Liability, Regulatory Issues, and Raw Materials Shortages Background of TMJ Research and Treatment "Dr. Enid Neidle, former director of scientific affairs for the American Dental Association (ADA), has described TMJ as "dentistry's hottest area of unorthodoxy and out-and-out quackery."1 Perhaps the historical perspective o Read More Go to Site

		Unconventional Dentistry: Part III. Legal and Regulatory Issues ^Votes:0 Unconventional Dentistry: Part III. Legal and Regulatory Issues Burton H. Goldstein , DMD, MS, FRCD(C) Abstract This is the third in a series of 5 articles providing a contemporary overview and introduction to unconventional dentistry (UD) and its correlation to unconventional medicine (UM). UD presents issues of dental quackery, fraud and malpractice, and it also engenders professional concerns about public protection and professional risks. Case reports illustrate numerous issues. The reader is encouraged to evaluate the cases for problems related to malpractice, fraud, ethics, behaviours and professionalism. A discussion of ethical issues is beyond the scope of this paper. MeSH Key Words: alternative medicine; dentistry; dentists/standards ? J Can Dent Assoc 2000; 66:503-6 Read More Go to Site

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