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
2353–2376 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 25, 2016
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond...
K161042 · KLE
Kuraray Noritake Dental, Inc.
Dental · 195d
Cleared Oct 24, 2016
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano...
K151399 · EBF
Schutz-Dental GmbH
Dental · 517d
Cleared Oct 21, 2016
KJ Mini Implant System
K151970 · DZE
Kj Meditech Co., Ltd.
Dental · 463d
Cleared Oct 20, 2016
OPTIMUS CMF SYSTEM
K160363 · JEY
Osteonic Co., Ltd.
Dental · 254d
Cleared Oct 19, 2016
ADAMANT ZIRCONIA DISC
K160203 · EIH
Adamant Co., Ltd.
Dental · 265d
Cleared Oct 18, 2016
Premier Sealant
K161580 · EBC
Premier Dental Company Products
Dental · 132d
Cleared Oct 17, 2016
OSSTEM Implant System
K161604 · DZE
Osstem Implant Co., Ltd.
Dental · 129d
Cleared Oct 14, 2016
BracePaste Adhesive
K160782 · DYH
American Orthodontics
Dental · 206d
Cleared Oct 14, 2016
IH Implant System
K153521 · DZE
Sewonmedix, Inc.
Dental · 311d
Cleared Oct 07, 2016
Straumann Sterile Healing Solution
K161677 · NHA
Institut Straumann AG
Dental · 112d
Cleared Oct 06, 2016
Quantum LB
K161684 · DYH
Reliance Orthodontic Products, Inc.
Dental · 111d
Cleared Oct 06, 2016
Pour Acrylic
K161330 · EBI
Dentsply Sirona
Dental · 147d
Cleared Oct 03, 2016
DMi Dental Implant System
K160060 · DZE
Dmi Innovative Medical Technology , Ltd.
Dental · 265d
Cleared Sep 30, 2016
i-Sil
K161774 · ELW
Spident Co., Ltd.
Dental · 94d
Cleared Sep 30, 2016
TempoCem Clear
K160443 · EMA
Dmg USA, Inc.
Dental · 226d
Cleared Sep 29, 2016
CreoDent Solidex Custom Abutment
K160436 · NHA
Creodent Prosthetics, Ltd.
Dental · 225d
Cleared Sep 29, 2016
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small...
K160410 · EFB
Dental Savings Club
Dental · 226d
Cleared Sep 28, 2016
PINK CAD/CAM disc
K153546 · EBI
Polident D.O.O., Dental Products...
Dental · 292d
Cleared Sep 27, 2016
TPH Spectra+ Universal Composite Restorative
K162107 · EBF
Dentsply Sirona
Dental · 60d
Cleared Sep 27, 2016
CDB Self Ligating Bracket 8F
K160957 · NJM
Cdb Corporation
Dental · 175d
Cleared Sep 27, 2016
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825 · EKX
Dentsply Sirona
Dental · 186d
Cleared Sep 23, 2016
O2VENT T
K161832 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 80d
Cleared Sep 21, 2016
ATLANTIS ISUS Implant Suprastructures
K160207 · NHA
Dentsply International, Inc.
Dental · 237d
Cleared Sep 20, 2016
SomnoDent ALPHA
K162306 · LRK
Somnomed, Inc.
Dental · 34d