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
2233–2256 of 12,659
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