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
2185–2208 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 08, 2017
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated...
K162948 · MVL
Kerr Corporation
Dental · 291d
Cleared Aug 04, 2017
REVEAL Bulk
K171147 · EBF
Bisco, Inc.
Dental · 107d
Cleared Aug 04, 2017
Life Essence Universal Porcelain System
K163251 · EIH
Blue Sky Bio
Dental · 259d
Cleared Aug 04, 2017
Nucleoss Tpure Implant System
K160850 · DZE
Sanlilar Tibbi Cihazlar Med....
Dental · 494d
Cleared Aug 01, 2017
Zirconia Dental Ceramics
K170894 · EIH
Chengdu Besmile Biotechnology Co., Ltd.
Dental · 127d
Cleared Aug 01, 2017
DD cubeX2 HS
K170885 · EIH
Dental Direkt GmbH
Dental · 127d
Cleared Jul 31, 2017
Obturys
K170207 · KIF
Itena Clinical
Dental · 188d
Cleared Jul 27, 2017
SML-OSA2 Appliances
K162816 · LQZ
Selane Products, Inc.
Dental · 294d
Cleared Jul 26, 2017
HygePLUS Alginate Impression Material
K170812 · ELW
Hygedent, Inc.
Dental · 131d
Cleared Jul 26, 2017
MagDen Dental Implant System
K162867 · DZE
Shinhung Mst Co., Ltd.
Dental · 286d
Cleared Jul 24, 2017
MP LeFort I Plates
K171364 · JEY
Stryker
Dental · 76d
Cleared Jul 24, 2017
Custom Bars
K162633 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 306d
Cleared Jul 18, 2017
Inspire ICE aka Inspire ICE Clear Brackets
K171844 · NJM
Ormco Corporation
Dental · 28d
Cleared Jul 18, 2017
CreoDent Solidex Customized Abutment and Screw
K170100 · NHA
Creodent Prosthetics, Ltd.
Dental · 188d
Cleared Jul 18, 2017
OSSIX BONE
K163714 · NPM
Datum Dental, Ltd.
Dental · 200d
Cleared Jul 18, 2017
Demi Ultra
K163064 · EBZ
Kerr Corporation
Dental · 258d
Cleared Jul 18, 2017
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
K162856 · EGS
Bonart Co., Ltd.
Dental · 279d
Cleared Jul 14, 2017
Neodent Implant System - GM Line
K163194 · DZE
Jjgc Industria E Comercio DE...
Dental · 241d
Cleared Jul 14, 2017
Bonafix TWO - Dental Implant System
K162853 · DZE
Bonafix Surgical and Dental Implants
Dental · 276d
Cleared Jul 13, 2017
KATANA Zirconia Block
K170986 · EIH
Kuraray Noritake Dental, Inc.
Dental · 101d
Cleared Jul 11, 2017
O2Vent W
K171316 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 68d
Cleared Jul 07, 2017
Anorganic Bone Mineral in Delivery Applicator
K170541 · NPM
Collagen Matrix, Inc.
Dental · 134d
Cleared Jul 06, 2017
ClearPath Aligner
K162609 · NXC
Clearpath Orthodontics, Ltd.
Dental · 290d
Cleared Jul 05, 2017
TOKUYAMA CUREGRACE
K170549 · EBI
Tokuyama Dental Corporation
Dental · 131d