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
2425–2448 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 27, 2016
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
K153067 · KIF
Sybron Dental Specialties
Dental · 279d
Cleared Jul 27, 2016
Zeramex P6 Dental Implant System
K152385 · DZE
Dentalpoint AG
Dental · 338d
Cleared Jul 25, 2016
PacEndo Chlorhexidine
K160577 · KJJ
Pac-Dent International, Inc.
Dental · 146d
Cleared Jul 25, 2016
NobelProcera HT ML FCZ Implant Bridge and Framework
K160158 · NHA
Nobel Biocare AB
Dental · 180d
Cleared Jul 22, 2016
ST Internal Fixture System
K152787 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 301d
Cleared Jul 21, 2016
rainbow LS Block
K160144 · EIH
Genoss Co., Ltd.
Dental · 182d
Cleared Jul 21, 2016
SHOFU Enamel Conditioner
K160086 · EBF
Shofu Dental Corporation
Dental · 188d
Cleared Jul 21, 2016
BioHPP - breCAM.BioHPP
K152113 · EBF
Bredent GmbH & Co. KG
Dental · 358d
Cleared Jul 21, 2016
ET III Bio-SA Fixture System
K151626 · DZE
Hiossen, Inc.
Dental · 400d
Cleared Jul 20, 2016
NR Line Implant System
K153268 · DZE
Dentium Co., Ltd.
Dental · 251d
Cleared Jul 15, 2016
CAD/CAMouflage Milling Bock
K160425 · EBF
Prismatik Dentalcraft, Inc.
Dental · 150d
Cleared Jul 14, 2016
Amber Mill Series and Amber Press Series
K160102 · EIH
Hass Corp.
Dental · 177d
Cleared Jul 14, 2016
ShefaBone SCPC Resorbable Bone Graft
K153230 · LYC
The Implantech Inc./Shefabone
Dental · 251d
Cleared Jul 13, 2016
VALO Grand
K160551 · EBZ
Ultradent Products, Inc.
Dental · 135d
Cleared Jul 12, 2016
Apinator
K160123 · LRK
Allen J. Moses, Dds, Ltd.
Dental · 174d
Cleared Jul 12, 2016
Gradia Plus
K153325 · EBF
GC America, Inc.
Dental · 236d
Cleared Jul 08, 2016
AcceleDent Aura
K153048 · OYH
Orthoaccel Technologies, Inc.
Dental · 263d
Cleared Jul 06, 2016
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K153231 · EMA
GC America, Inc.
Dental · 240d
Cleared Jun 30, 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · ELW
Kerr Corporation
Dental · 134d
Cleared Jun 30, 2016
VITA ENAMIC Implant Solutions (IS)
K153645 · NHA
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 192d
Cleared Jun 30, 2016
Admira Fusion Flow
K153177 · EBF
Voco GmbH
Dental · 240d
Cleared Jun 30, 2016
Initial LiSi Press
K153136 · EIH
GC America, Inc.
Dental · 244d
Cleared Jun 28, 2016
LED Curing Light GT-2000
K153078 · EBZ
Monitex Industrial Co., Ltd.
Dental · 249d
Cleared Jun 23, 2016
CELALUX 3
K153018 · EBZ
Voco GmbH
Dental · 252d