Titan Implants I10C-4.2, 13

• FDA 510(k) K250806 decided 18 Jun 2026 Active
• FDA GUDID UDI-DI 07290111270949 listed 16 Aug 2026 Listed

1. 18 Jun 2026 Cleared FDA 510(k) K250806
2. 16 Aug 2026 Listed FDA GUDID 07290111270949

Trade name

Titan Implants

Generic name

Screw endosteal dental implant, two-piece

Model / Ref / Catalog

I10C-4.2, 13

Primary DI / UDI-DI

07290111270949

510(k) Number

K250806 ↗

FDA product code

DZE

GMDN term

Screw endosteal dental implant, two-piece

Device class

Class II

Regulation number

872.3640

GUDID distribution status

In Commercial Distribution

MRI safety

MR Safe

Other devices filed under FDA product code DZE (Implant, Endosseous, Root-Form).

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• ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT by ZIMMER DENTAL INC.
• s-Clean OneQ-SL Fixture DSSOFM3907S by DENTIS CO., LTD
• SQ-SL AXEL Fixture DSAFR5012X by DENTIS CO., LTD
• ANKYLOS® 31010403 by Dentsply Implants Manufacturing GmbH
• Cotec Dental Implant System by Cotec Implant Co., Ltd.
• The Prodigy System Dental Implants by BIOHORIZONS IMPLANT SYSTEMS INC.
• NC Healing Abutment, conical shape 121030 by BIO CONCEPT Co., Ltd.
• Branemark System Drill Controller by Nobelpharma USA, Inc.
• Interpore IMZ Single Tooth Attachment System by Interpore Intl.

• Titan Implants I10C-4.2, 10

  Class II

  FDA 510(k) K250806 Active Cleared 18 Jun 2026 GUDID on market

• Titan Implants I10C-4.2, 11.5

  Class II

  FDA 510(k) K250806 Active Cleared 18 Jun 2026 GUDID on market

• Titan Implants I10C-4.2, 16

  Class II

  FDA 510(k) K250806 Active Cleared 18 Jun 2026 GUDID on market

• Titan Implants I10C-5, 10

  Class II

  FDA 510(k) K250806 Active Cleared 18 Jun 2026 GUDID on market

See all devices from A.B. Dental Devices Ltd →