FDA.report

510(k) K231915

Device
Zfx Abutments
Applicant
Zfx GmbH - A Company of Zimvie
510(k) number
K231915
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-01
Date received
2023-06-29
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Ana Leitão
Address
Kopernikusstraße 15 Dachau DE 85221 85221

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
04251881713824GenTek® TiBase, TSV®/TM® Engaging, 3.5mmD x 4.7mmHZfx GmbH2024-03-27
04251881713503GenTek® TiBase, Certain® Engaging, 3.4mmD x 4.7mmHZfx GmbH2024-03-27
04251881713527GenTek® TiBase, Certain® Non-Engaging, 3.4mmD x 4.7mmHZfx GmbH2024-03-27
04251881713589GenTek® TiBase, Certain® Engaging, 5.0mmD x 4.7mmHZfx GmbH2024-03-27
04251881713602GenTek® TiBase, Certain® Non-Engaging, 5.0mmD x 4.7mmHZfx GmbH2024-03-27
04251881713749GenTek® TiBase, Eztetic® Engaging, 2.9mmD x 4.7mmHZfx GmbH2024-03-27
04251881713565GenTek® TiBase, Certain® Non-Engaging, 4.1mmD x 4.7mmHZfx GmbH2024-03-27
04251881703863GenTek® Hexalobular Retaining Screw, Eztetic®Zfx GmbH2024-03-27
04251881703764GenTek® Gold-Tite® Hexalobular Screw, Certain®, Non-EngagingZfx GmbH2024-03-27
04251881703740GenTek® Gold-Tite® Hexalobular Screw, Certain®, EngagingZfx GmbH2024-03-27
04251881703702GenTek® Retaining Screw, TSV®/Trabecular Metal®Zfx GmbH2024-03-27
04251881703627GenTek® Retaining Screw, Eztetic®Zfx GmbH2024-03-27
04251881703542GenTek® Large Gold-Tite Screw, Certain®Zfx GmbH2024-03-27
04251881703504GenTek® Hexed Gold-Tite Screw, Certain®Zfx GmbH2024-03-27
04251881703887GenTek® Hexalobular Retaining Screw, TSV®/TM®Zfx GmbH2024-03-27
04251881713763GenTek® TiBase, Eztetic® Non-Engaging, 2.9mmDx 4.7mmHZfx GmbH2024-03-27
04251881713848GenTek® TiBase, TSV®/TM® Non-Engaging, 3.5mmD x 4.7mmHZfx GmbH2024-03-27
04251881713862GenTek® TiBase, TSV®/TM® Engaging, 4.5mmD x 4.7mmHZfx GmbH2024-03-27
04251881713886GenTek® TiBase, TSV®/TM® Non-Engaging, 4.5mmD x 4.7mmHZfx GmbH2024-03-27
04251881713909GenTek® TiBase, TSV®/Trabecular Metal®, Engaging, 5.7mmD x 4.7mmHZfx GmbH2024-03-27
04251881713923GenTek® TiBase, TSV®/Trabecular Metal®, Non-Engaging, 5.7mmD x 4.7mmHZfx GmbH2024-03-27
04251881714128GenTek® Angulated Screw Channel TiBase, Eztetic® Engaging, 2.9mmD x 1.7mmCHZfx GmbH2024-03-27
04251881714142GenTek® Angulated Screw Channel TiBase, Eztetic® Non-Engaging, 2.9mmD x 1.7mmCHZfx GmbH2024-03-27
04251881714166GenTek® Angulated Screw Channel TiBase, TSV®/TM® Engaging, 3.5mmD x 0.3mmCH Zfx GmbH2024-03-27
04251881714180GenTek® Angulated Screw Channel TiBase, TSV®/TM® Non-Engaging, 3.5mm x 0.3mmCHZfx GmbH2024-03-27
04251881714203GenTek® Angulated Screw Channel TiBase, TSV®/TM® Engaging, 4.5mmD x 0.3mmCH Zfx GmbH2024-03-27
04251881714227GenTek® Angulated Screw Channel TiBase, TSV®/TM® Non-Engaging, 4.5mmD x 0.3mmCHZfx GmbH2024-03-27
04251881714241GenTek® Angulated Screw Channel TiBase, TSV®/TM® Engaging, 5.7mmD x 0.3mmCH Zfx GmbH2024-03-27
04251881714265GenTek® Angulated Screw Channel TiBase, TSV®/TM® Non-Engaging, 5.7mmD x 0.3mmCHZfx GmbH2024-03-27
04251881714289GenTek® Angulated Screw Channel TiBase, Certain® Engaging, 3.4mmD x 1.3mmCHZfx GmbH2024-03-27

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