3.25mm ERA Dental Implant System Statement Letter: Sterngold C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432 Re: K041271 Trade/Device Name: 3.25mm ERA Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: LI Product Code: DZE Dated: August 20, 2004 Received: August 23, 2004 Dear Ms. Papineau: We have reviewed your Section 510(k) prema ...

31 Dental Implants Statement Letter: Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 334 10 Re: KO30614 Trade/Device Name: 31 Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: DZE Dated: June 19, 2003 Received: June 20, 2003 Dear Ms. Hughes: We have reviewed your Section 5 1 O(k) premarket notification of int ...

3A Dental Implant System Statement Letter Osseco Biosource, Limited C/O Ms. Michele H. Vovolka Vantage Consulting International, Litimed P.O. Box 848 Grayslake, Illinois 60030 Re: KO1 1879 Trade/Device Name: 3A Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: DZE Dated: May 27,2002 Received: May 29,2002 Dear Ms. Vovolka: We have reviewed your Section 5 1 O(k) premarket notification of intent to market the de ...

3i Dental Accessories Statement Letter Ms. Jeanette G. Dailey Regulatory Affairs Manager Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Re: KO221 13 Trade/Device Name: 3 i Dental Implant Accessories Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: I11 Product Code: DZE Dated: June 27,2002 Received: June 28,2002 Dear Ms. Dailey: We have reviewed your Section 5 10(k) premarket notification of intent t ...

3i Patient-Specific Dental Abutments and Overdenture Bars Statement Letter: Ms. Jeannette G. Dailey Regulatory Affairs Manager implant innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Re: K032263 Trade/Device Name: 3i Patient-Specific Dental Abutments and Overdenture Bars Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 29, 2003 Received: October 30, 2003 Dear Ms. Dailey: ...

5.0 x 5mm Endopore@ Endosseous Dental Implant System Statement Letter: Innova Life Sciences Corporation Mr. Howard M. Holstein Regulatory Counsel Hogan & Hartson, L.L.P. 555 13'h Street N.W. Washington, DC 20004 Re: KO32140 Trade/Device Name: 5.0 x 5mm Endopore@ Endosseous Dental Implant System Regulation Number: 872.3 640 Regulation Name: Endosseous Implant Regulatory Class: 111 Product Code: DZE Dated: July 11,2003 Received: July 11,2003 Dear Mr. Holstein: We have reviewed you ...

6.0 x 5.7mm Dental Implant Statement Letter Only: Dr. Vincent J. Morgan President Bicon, Incorporated 123 Morton Street, 2'ld Floor Boston, Massachusetts 02 130 Re: KO10185 Trade/Device Name: 6.0 x 5.7mm Dental Implant Regulation Number: 8 72.3 640 Regulation Name: Endosseous Implant Regulatory Class: 111 Product Code: DZE Dated: November 1, 2002 Received: November 4,2002 Dear Dr. Morgan: We have reviewed your Section 5 1 O(k) premarket notification of intent to market the device ...

American Dental Implant Statement Only: Mr. Steven B. Lombardi President American Dental Implant Corporation 2415 Wilmington Road New Castle, Pennsylvania 16105 Re: K042462 Trade/Device Name: American Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: LI Product Code: DZE Dated: August 25, 2004 Received: September 10, 2004 Dear Mr. Lombardi: We have reviewed your Section 5 10(k) premarket notification of intent to market the device re ...

ANKYLOS® Dental Implant System Statement Letter: FRIADENT GmbH C/O Ms. Carol Patterson Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630 Re: K041509 Trade/Device Name: ANKYLOS® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 13, 2004 Received: August 17, 2004 Dear Ms. Patterson: We have reviewed your Section 510(k) premarket notification of intent to mar ...

Astra Tech Implants - Dental System Fixture OsseoSpeed; Dental System Fixture MicroMacro (new indication) Statement Letter: Astra Tech,, Incorporated C/O Mr. Bruce R. Manning New England BioMedical Research, Incorporated 96 West Main Street P.O. Box 809 Northborough, Massachusetts 01 532 Re: KO241 11 Trade/Device Name: Astra Tech Implants- Dental System Fixture OsseoSpeed Dental System Fixture MicroMacro (new indication) Regulation Number: 872.3640 Regulation Name: Endosseous Implant ...

Astra Tech Implants - Dental System ‘Ceramic Abutment’ Summary Only: Sponsor Name Astra Tech, INC. 430 Bedford St, Suite 100 Lexington, MA 02240 Device Name Proprietary Name: Astra Tech Implants - Dental System ‘Ceramic Abutment’ Common Name: Dental Implant Classification name: Endosseous Dental Implant (21 CFR 872.3640) Identification of Legally Marketed Device o Astra Tech Implants - Dental System ‘Prepable Abutment System’ K974738 o Nobel BioCare Ceradapt K number unknown o 3i Z ...

Astra Tech Implants Dental System Statement Letter: Astra Tech, Incorporated CdO Mr. Bruce R. Manning New England Biomedical Research, Incorporated 96 West Main Street P.O. Box 809 Nortliborough, Massachusetts 01532 Re: K04l492 Trade/Device Name: Astra Tech Implants - Dental System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: LI Product Code: DZE Dated: June 3, 2004 Received: June 4, 2004 Dear Mr. Manning: We have reviewed your Section ...

BASIC Dental Implant System Post and Core - Thin Attachment Statement Letter: Mr. Dan Blacklock Vice President BASIC Dental Implant Systems, Incorporated 3321 Columbia NE Albuquerque, New Mexico 871 07 Re: KO22912 Trade/Device Name: BASIC Dental Implant System Post & Core-Thin Attachment Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: DZE Dated: August 28. 2002 Received: September 3, 2002 Dear Mr. Blacklock: We have reviewed you ...

Branemark- Integration Dental Implant and Accessories Statement Letter: Ms. Jan-Olof Djerf Quality management & Regulatory Affairs, Manager Branemark Integration A.B. Lilla Bommen 1 SE-411 04 Gothenburg SWEDEN Re: K040643 Trade/Device Name: Brinemark Integration Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 5, 2004 Received: March 11, 2004 Dear Ms. Djerf: We have reviewed your Secti ...

FRIALIT® PLUS Dental Implant System Statement Letter: FRIADENT GmbH C/O Ms. Carol White President Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630 Re: K040170 Trade/Device Name: FRIADENT PLUS Dental Implant Systems Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: July 28, 2004 Received: August I, 2004 Dear Ms. White: We have reviewed your Section 510(k) premarket notification of in ...

Hybrid Endopore® Endosseous Dental Implant System Statement Letter: Innova LifeSciences Corporation Mr. Howard M. Holstein C/O Mr. Hogan & Hartson L.L.P. 555; Thirteenth Street N.W. Washington D.C. 20004 Re: K040714 Trade/Device Name: Hybrid Endopore® Endosseous Dental Implant System Regulation Number: 872. 3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: March 17, 2004 Received: March 18, 2004 Dear Mr. Holstein: We: have reviewed your Sect ...

ITI Dental Implant System Statement Letter: Institut Straumann AG C/O Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA 1601 Trapelo Road Waltham, Massachusetts 02451 Re: K033984 Trade/Device Name: ITI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 13, 2004 Received: April 14, 2004 Dear Ms. Jalbert: We have reviewed your Section 510(k) premarket notification of intent to ...

Klockner Dental Implants, Models SK, NK, IK, S3, and S4 Statement Letter Only: Ms. Mercedes Roldan Soadco, S. L. AV Fiter I Rossell 4 Bis Local 2 Escaldes-Engorydany, ANDORRA Re: KO10132 Trade/Device Name: Klockner Denta Regulation Number: 872.3640 Implants, Models SK, NK, IK, S3, and S4 Regulation Name: Dental Endosseous Implant Regulatory Class: 111 Product Code: DZE Dated: March 4,2002 Received: March 7,2002 Dear Ms. Roldan: We have reviewed your Section 5 lO(k) premarket no ...

MIS Dental Implant System Statement Letter: MIS-Implant Technologies Limited C/O Mr. Motti Weisman Vice President Marketing MIS Implants Technologies, Incorporated 278 Broadway Elmwood Park, New Jersey 07407 Re: K040807 Trade/Device Name: MIS Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE, NHA Dated: April 22, 2004 Received: April 27, 2004 Dear Mr. Weisman: We have reviewed your Section 510(k) premark ...

OCO Dental Implant (5.0 mm Diameter) Statement Letter Only: Mr. David D. Dalise President “0” Company, Incorporated 600 Paisano NE. Suite A Albuquerque, New Mexico 87123 Re: KO23336 Trade/Device Name: OCO Dental Implant (5.0 mm Diameter) Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: DZE Dated: September 27, 2002 Received: October 7, 2002 Dear Mr. Dalise: We have reviewed your Section 5 1 O(k) premarket notification of intent t ...

Porta Implant Statement Letter Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75 179 Pforzheim GERMANY Re: KO30312 Trade/Device Name: Porta Implant Regulation Number: 21 CFR 872.3060 Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: I1 Product Codes: EJT Dated: January 27,2003 Received: January 30,2003 Dear Dr. Polzer: We have reviewed your Section 5 10(k) premarket no ...

Premier Implant Cement, Model 3001450 Statement Only: Premier Dental Products Corporation C/O Mr. Barry Hale C.Q.E 7707 E 201 Terr Belton, Missouri 64012 Re: K033309 Trade/Device Name: Premier Implant Cement, Model 3001450 Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 14, 2004 Received: January 20, 2004 Dear Mr. Hale: We have reviewed your Section 510(k) premarket notification of intent to market the device referen ...

Scalloped Endopore® Endosseous Dental Implant System Statement Letter: Mr. Howard M. Holstein Innova LifeSciences Corporation 555 Thirteenth Street, NW Washington, DC 20004-1109 Re: K043190 Trade/Device Name: Scalloped Endopore Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 10, 2004 Received: December 10, 2004 Dear Mr. Holstein: We have reviewed your Section 5 10(k) premarket n ...

SPI@ ELEMENT Dental Implant 0 3.5 mm Summary Letter: Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130 Re: KO30689 Trademevice Name: SPI@ ELEMENT Dental Implant 0 3.5 mm Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: DZE Dated: March 4,2003 Received: March 4,2003 Dear Mr. Larson: We have reviewed your Section 5 1 O(k) premarket notification of intent to market the devi ...

SPI® CONTACT Dental Implant Statement Letter: Thommen Medical, AG C/O Ms. Floyd G. Larson President Paxmed International 4329 Graydon Road San Diego, California 92130 Re: K034014 Trade/Device Name: SPI Contact dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: lII Product Code: DZE Dated: December 22, 2003 Received: December 24, 2003 Dear Ms. Larson: We have reviewed your Section 510(k) premarket notification of intent to market the ...

SPl@ Dental Implant Abutments Statement Letter: Thommen Medical, AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130 Re: KO31747 Trademevice Name: SPI Dental Implant Abutment Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: NHA Dated: June 3,2003 Received: June 5,2003 Dear Mr. Larson: We have reviewed your Section 5 1 O(k) premarket notification of intent to market the device refer ...

SPl@ EASY Dental Implant Protective Cap Statement Letter: Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130 Re: KO33346 Trademevice Name: SPI@ EASY Dental Implant Protective Cap Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: NHA Dated: October 17,2003 Received: October 20, 2003 Dear Mr. Larson We have reviewed your Section 5 1 O(k) premarket notification of intent to m ...

Sterngold Acid Etch Dental Implant System Statement Letter: Sterngold C/O Ms. Pamela Papineau Delphi Medical Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432 Re: KO23580 TradeDevice Name: Sterngold Acid Etch Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant System Regulatory Class: I11 Product Code: DZE Dated: October 21,2002 Received: October 24,2002 Dear Ms. Papineau: We have reviewed your Section 5 10(k) premarket notific ...

The 5.0.x 6.0mm Dental Implant Statement Only Dr. Vincent Morgan Bicon, Incorporated 501 Arborway Boston, Massachusetts 02130 Re: K042637 Trade/Device Name: The 5.0.x 6.0mm Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: IX Product Code: DZE Dated: September 24, 2004 Received: September 27, 2004 Dear Dr. Morgan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deter ...

The Prodigy System Dental Implants Statement Letter Mr. Winston D. Greer Director, Quality Assurance & Regulatory Affairs Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243 Re: K042429 Trade/Device Name: Biollorizons The Prodigy SystemTM Endosseous Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2004 Received: September 8, 2004 Dear Mr. Gre ...

TITAN Dental Implant System Statement Letter: Titan Implants, Incorporated C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130 Re: K042971 Trade/Device Name: TITAN Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: October 25, 2004 Received: October 28, 2004 Dear Mr. Larson: We have reviewed your Section 510(k) premarket notification of intent to market t ...

Titanium coping for IT1 anterior implant Summary Information: Applicant’s Name and Address Straumann USA (on behalf of lnstitut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781 -890-0001 Fax Number: 781 -890-6464 Contact Person: Linda Jalbert Director, Regulatory Affairs Name of the Device Trade Name: Titanium coping for IT1 anterior implant Common Name: Endosseous dental implants Classification Name: Endosseous dental implants 21 CFR 872.364 ...

Summary Only: SUBMITTER INFORMATION Company Name: FRIADENT GmbH. Company Address: Steinzeugstrasse 50 Mannheim D-68229 Germany Company Phone: (01 1) 49 06 21 4 86 1549 (01 1) 49 06 21 4 86 1866 Company Facsimile: Contact Person: Heike Dietzler Regulatory Affairs Manager Date Summary Prepared: February 27,2003 DEVICE IDENTIFICATION TradeRroprietary Name: XiVE@ 3.0 Dental Implant System Classification Name: Endosseous Dental Implants 21 CFR 872.3640 DEVICE DESCRIPTION The XiVE 3 .O ...

XiVE@ TG Dental Implant System Statement Letter: FRIADENT GmbH C/O Ms. Carol Patterson Patterson Consulting Group, Incorporated 2191 1 Erie Lane Lake Forest, California 92630 Re: KO32284 Trademevice Name: XiVE@ TG Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: I11 Product Code: DZE Dated: July 22,2003 Received: July 24,2003 Dear Ms. Patterson: We have reviewed your Section 5 1 O(k) premarket ndfication of intent to market t ...