Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Dental ×
12,659 results
1369–1392 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 02, 2021
Porcine Mineral Collagen Composite
K202183 · NPM
Collagen Matrix, Inc.
Dental · 241d
Cleared Mar 30, 2021
BOMEDENT Apex locator, WISMY Apex locator
K203836 · LQY
Changzhou Bomedent Medical Technology...
Dental · 90d
Cleared Mar 30, 2021
E-Denture Pro
K203641 · EBI
Envisiontec GmbH
Dental · 106d
Cleared Mar 29, 2021
LumiCare Caries Diagnostic Rinse
K200601 · LFC
GreenMark Biomedical, Inc.
Dental · 385d
Cleared Mar 26, 2021
TruAbutment DS, TruBase S
K201197 · NHA
Truabutment, Inc.
Dental · 326d
Cleared Mar 25, 2021
DiaPaste
K210333 · KIF
DiaDent Group International
Dental · 48d
Cleared Mar 24, 2021
White ENDOSEAL MTA
K202015 · KIF
Maruchi
Dental · 246d
Cleared Mar 23, 2021
DIOnavi-Denture02
K210828 · EBI
Dio Corporation
Dental · 4d
Cleared Mar 22, 2021
Spark Clear Aligner System
K203737 · NXC
Ormco Corporation
Dental · 90d
Cleared Mar 18, 2021
HySil Plus Impression Materials
K210041 · ELW
Osstem Implant Co., Ltd.
Dental · 70d
Cleared Mar 18, 2021
s-Clean SQ-SL Implant System Mini
K202773 · DZE
Dentis Co., Ltd.
Dental · 178d
Cleared Mar 18, 2021
Straumann Immediate Temporary Abutments
K201681 · NHA
Institut Straumann AG
Dental · 269d
Cleared Mar 16, 2021
Multi-unit Abutments for CONELOG
K203252 · NHA
BioHorizons Implant Systems, Inc.
Dental · 132d
Cleared Mar 15, 2021
Neodent Implant System-Easy Pack
K203382 · DZE
Jjgc Industria E Comercio DE...
Dental · 118d
Cleared Mar 12, 2021
VENUS Bracket, ROSE Bracket
K201410 · NJM
Gni Co., Ltd.
Dental · 288d
Cleared Mar 12, 2021
Endo Motor
K192649 · EKX
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 535d
Cleared Mar 10, 2021
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic...
K203606 · LRK
Meris Investment Group
Dental · 90d
Cleared Mar 10, 2021
Non-Sterile Zirconia Block
K201492 · EIH
Bioden Co., Ltd.
Dental · 279d
Cleared Mar 08, 2021
Perfit ZR HT Dental Zirconia blank
K203351 · EIH
Vatech Acucera, Inc.
Dental · 115d
Cleared Mar 03, 2021
Geistlich Mucograft®, Geistlich Mucograft® Seal
K210280 · NPL
Geistlich Pharma AG
Dental · 30d
Cleared Mar 01, 2021
VALO Grand Corded and Accessory Lenses
K210550 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Feb 26, 2021
Ultrafast, Ultrafast Plus, Ultrafast Lite
K201387 · NVK
Dentlight, Inc.
Dental · 275d
Cleared Feb 26, 2021
AsoAligner
K201104 · NXC
Aso International Manila, Inc.
Dental · 308d
Cleared Feb 26, 2021
Archworx
K173738 · NXC
Utah Medical Products and Services
Dental · 1178d