FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×

12,611 results

1993–2016 of 12,611

Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental

Cleared Jun 11, 2018

BeautiCem Veneer Kit

Shofu Dental Corporation

Cleared Jun 11, 2018

Ti-one 101 TS Dental Implant System

Hung Chun Bio-S Co., Ltd.

Cleared Jun 08, 2018

Piccolo Implants and Accessories

Southern Implants (Pty), Ltd.

Cleared Jun 07, 2018

Ivoclar Vivadent, AG

Cleared Jun 05, 2018

Straumann BLX Implant System

Institut Straumann AG

Cleared Jun 01, 2018

UF(II) Wide Fixture

Dio Corporation

Cleared Jun 01, 2018

Smart Moves Complete

Great Lakes Orthodontics, Ltd.

Cleared May 29, 2018

Good Doctors Co., Ltd.

Cleared May 24, 2018

IS-III HActive Fixture

Neobiotech Co., Ltd.

Cleared May 24, 2018

Cleared May 23, 2018

Rodo Medical, Inc.

Cleared May 18, 2018

ArgenIS Titanium Abutments

Argen Corporation

Cleared May 16, 2018

Cleared May 15, 2018

Meta Biomed Co., Ltd.

Cleared May 14, 2018

Dentium Implantium & SuperLine Prosthetics

Dentium Co., Ltd.

Cleared May 10, 2018

OKTAGON Implant System

Hager& Meisinger GmbH

Cleared May 08, 2018

Cleared May 04, 2018

URIS OMNI System

Truabutment, Inc.

Cleared May 04, 2018

3.0 Dynamic TiBase

Talladium Espana, SL

Cleared May 03, 2018

Satelec - Acteon Group

Cleared May 03, 2018

Smartcord, Smartcord X

Eastdent Co., Ltd.

Cleared May 03, 2018

Fluorescence Mode

Carl Zeiss Suzhou Co., Ltd.

Cleared Apr 27, 2018

Mycone Dental Supply Company, Inc....

Cleared Apr 26, 2018

P50 Series Dental Operative Unit and Accessories