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
2737–2760 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 03, 2015
Monobond Etch & Prime
K150164 · KLE
Ivoclar Vivadent, AG
Dental · 67d
Cleared Apr 03, 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575 · ELW
Ivoclar Vivadent, Inc.
Dental · 107d
Cleared Apr 02, 2015
J2A Dental Implant System, J2C Dental Implant System
K150060 · DZE
Kj Meditech Co., Ltd.
Dental · 79d
Cleared Apr 02, 2015
Hahn Tapered Implant System
K143353 · DZE
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Apr 01, 2015
Argulated Locking Plates
K143338 · JEY
Osteomed LP
Dental · 132d
Cleared Apr 01, 2015
Biomet Microfixation OmniMax MMF System
K143336 · JEY
Biomet Microfixation
Dental · 132d
Cleared Mar 27, 2015
EBI External Implant System
K142426 · DZE
Ebi, Inc.
Dental · 210d
Cleared Mar 26, 2015
DD cubeX2
K150196 · EIH
Dental Direkt GmbH
Dental · 56d
Cleared Mar 25, 2015
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
K143104 · EBF
Kettenbach GmbH & Co. KG
Dental · 147d
Cleared Mar 23, 2015
IBS IMPLANT SYSTEM
K140806 · DZE
Innobiosurg Co., Ltd.
Dental · 356d
Cleared Mar 20, 2015
BIOMATE DENTAL IMPLANT SYSTEM
K142174 · DZE
Biomate Medical Devices Technology...
Dental · 225d
Cleared Mar 18, 2015
DMRC Self-Cure Bracket Adhesive One Step and Primer
K142886 · DYH
Danville Materials, LLC
Dental · 167d
Cleared Mar 18, 2015
SYNTEC WETALI ORTHODONTIC MINI SCREWS
K142001 · OAT
Syntec Scientific Corporation -...
Dental · 238d
Cleared Mar 13, 2015
Dental Unit
K142206 · EIA
Zhuhai Siger Medical Equipment Co., Ltd.
Dental · 214d
Cleared Mar 11, 2015
KONUS DENTAL IMPLANT SYSTEM
K141159 · DZE
Argon Med. Productions Vertriebs...
Dental · 310d
Cleared Mar 09, 2015
PACSEAL PIT & FISSURE SEALANT
K141717 · EBC
Pac-Dent International, Inc.
Dental · 257d
Cleared Feb 27, 2015
KATANA Zirconia
K143439 · EIH
Kuraray Noritake Dental, Inc.
Dental · 87d
Cleared Feb 27, 2015
EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED...
K141183 · EFB
Ttbio Corp.
Dental · 296d
Cleared Feb 27, 2015
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
K140990 · ELC
E.M.S Electro Medical Systems S.A
Dental · 316d
Cleared Feb 26, 2015
PANAVIA SA Cement Plus Handmix
K142623 · EMA
Kuraray Noritake Dental, Inc.
Dental · 163d
Cleared Feb 26, 2015
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · KIF
Dentsply International, Inc.
Dental · 202d
Cleared Feb 25, 2015
Irritrol, EDS Combo-Rinse
K150020 · KJJ
Essential Dental Systesm, Inc.
Dental · 50d
Cleared Feb 24, 2015
EAZY PRIMER
K142848 · KLE
Parkell, Inc.
Dental · 147d
Cleared Feb 24, 2015
T-8000 THEROZONE UNIT
K141504 · EIA
Therozone USA, Inc.
Dental · 263d