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510K Submissions

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3.25mm ERA Dental Implant System
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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, Massach READ MORE
http://www.fda.gov/cdrh/pdf4/k041271.pdf

31 Dental Implants
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31 Dental Implants Statement Letter: Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 3 READ MORE
http://www.fda.gov/cdrh/pdf3/k030614.pdf

3A Dental Implant System
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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 Tra READ MORE
http://www.fda.gov/cdrh/pdf/k011879.pdf

3i Dental Accessories
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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 T READ MORE
http://www.fda.gov/cdrh/pdf2/k022113.pdf

3i Patient-Specific Dental Abutments and Overdenture Bars
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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 G READ MORE
http://www.fda.gov/cdrh/pdf3/k032263.pdf

5.0 x 5mm Endopore@ Endosseous Dental Implant System
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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. Wa READ MORE
http://www.fda.gov/cdrh/pdf3/k032140.pdf

6.0 x 5.7mm Dental Implant
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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: READ MORE
http://www.fda.gov/cdrh/pdf/k010185.pdf

Affordable Dental Implants and Periodontal Surgery
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American Dental Health Providers dental office provides affordable dental implants, cheap dental implants, cost dental implants dental implant specialists for affordable dental fees. READ MORE
http://www.adhp.com/

American Dental Implant
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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: READ MORE
http://www.fda.gov/cdrh/pdf4/k042462.pdf

ANKYLOS¨? Dental Implant System
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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 READ MORE
http://www.fda.gov/cdrh/pdf4/k041509.pdf

Astra Tech Implants - Dental System ǃÚCeramic AbutmentǃÙ
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Astra Tech Implants - Dental System ǃÚCeramic Abutmentǃ٠Summary Only: Sponsor Name Astra Tech, INC. 430 Bedford St, Suite 100 Lexington, MA 02240 Device Name Proprietary Name: Astra Tech Imp READ MORE
http://www.fda.gov/cdrh/pdf2/k023631.pdf

Astra Tech Implants - Dental System Fixture OsseoSpeed; Dental System Fixture MicroMacro (new indication)
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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 BioMedica READ MORE
Astra Tech Implants - Dental System Fixture OsseoSpeed; Dental System Fixture Mi...

Astra Tech Implants Dental System
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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 Nortliboroug READ MORE
http://www.fda.gov/cdrh/pdf4/k041492.pdf

BASIC Dental Implant System Post and Core - Thin Attachment
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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 READ MORE
http://www.fda.gov/cdrh/pdf2/k022912.pdf

Branemark- Integration Dental Implant and Accessories
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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 Go READ MORE
http://www.fda.gov/cdrh/pdf4/k040643.pdf

FRIALIT¨? PLUS Dental Implant System
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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: K0 READ MORE
http://www.fda.gov/cdrh/pdf4/k040170.pdf

Hybrid Endopore¨? Endosseous Dental Implant System
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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 READ MORE
http://www.fda.gov/cdrh/pdf4/k040714.pdf

ITI Dental Implant System
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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 T READ MORE
http://www.fda.gov/cdrh/pdf3/k033984.pdf

Klockner Dental Implants, Models SK, NK, IK, S3, and S4
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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 Trad READ MORE
http://www.fda.gov/cdrh/pdf/k010132.pdf

MIS Dental Implant System
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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, Ne READ MORE
http://www.fda.gov/cdrh/pdf4/k040807.pdf

OCO Dental Implant (5.0 mm Diameter)
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OCO Dental Implant (5.0 mm Diameter) Statement Letter Only: Mr. David D. Dalise President ǃ?0ǃ? Company, Incorporated 600 Paisano NE. Suite A Albuquerque, New Mexico 87123 Re: KO23336 Trade/ READ MORE
http://www.fda.gov/cdrh/pdf2/k023336.pdf

Porta Implant
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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/Devi READ MORE
http://www.fda.gov/cdrh/pdf3/k030312.pdf

Premier Implant Cement, Model 3001450
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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 READ MORE
http://www.fda.gov/cdrh/pdf3/k033309.pdf

Scalloped Endopore¨? Endosseous Dental Implant System
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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 Tr READ MORE
http://www.fda.gov/cdrh/pdf4/k043190.pdf

SPI@ ELEMENT Dental Implant 0 3.5 mm
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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: READ MORE
http://www.fda.gov/cdrh/pdf3/k030689.pdf

SPI¨? CONTACT Dental Implant
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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/Devic READ MORE
http://www.fda.gov/cdrh/pdf3/k034014.pdf

SPl@ Dental Implant Abutments
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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 READ MORE
http://www.fda.gov/cdrh/pdf3/k031747.pdf

SPl@ EASY Dental Implant Protective Cap
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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 READ MORE
http://www.fda.gov/cdrh/pdf3/k033346.pdf

Sterngold Acid Etch Dental Implant System
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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 Tr READ MORE
http://www.fda.gov/cdrh/pdf2/k023580.pdf

The 5.0.x 6.0mm Dental Implant
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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 Regu READ MORE
http://www.fda.gov/cdrh/pdf4/k042637.pdf

The Prodigy System Dental Implants
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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 READ MORE
http://www.fda.gov/cdrh/pdf4/k042429.pdf

TITAN Dental Implant System
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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 N READ MORE
http://www.fda.gov/cdrh/pdf4/k042971.pdf

Titanium coping for IT1 anterior implant
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Titanium coping for IT1 anterior implant Summary Information: ApplicantǃÙs Name and Address Straumann USA (on behalf of lnstitut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 0245 READ MORE
http://www.fda.gov/cdrh/pdf3/k032498.pdf

XiVE@ 3.0 Dental Implant System
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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 READ MORE
http://www.fda.gov/cdrh/pdf3/k030639.pdf

XiVE@ TG Dental Implant System
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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 Trade READ MORE
http://www.fda.gov/cdrh/pdf3/k032284.pdf
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