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
1969–1992 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 24, 2018
Dental High-speed Handpiece and Accessories
K173943 · EFB
Microp Technology (Taiwan), Inc.
Dental · 210d
Cleared Jul 20, 2018
The Graft Natural Bone Substitute
K173188 · NPM
Purgo Biologics, Inc.
Dental · 291d
Cleared Jul 18, 2018
ATLANTIS Conus Structure
K181189 · NHA
Dentsply Sirona
Dental · 76d
Cleared Jul 17, 2018
Straumann Variobase for Bridge/Bar Cylindrical
K173968 · NHA
Institut Straumann AG
Dental · 200d
Cleared Jul 13, 2018
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M...
K181134 · LFD
Sunstar Americas, Inc.
Dental · 74d
Cleared Jul 12, 2018
AIM2
K181011 · ELW
GC America, Inc.
Dental · 86d
Cleared Jul 12, 2018
Estelite Universal Flow
K180613 · EBF
Tokuyama Dental Corporation
Dental · 126d
Cleared Jul 11, 2018
High-speed Turbine Handpieces for Single Use
K172543 · EFB
Beijing Dongbo Dental Handpiece Co.,...
Dental · 322d
Cleared Jul 10, 2018
TruMatch CMF Titanium 3D Printed Implant
K173039 · JEY
Materialise NV
Dental · 285d
Cleared Jul 10, 2018
Advanced Dental Applicance
K172991 · LRK
Dasoft Partners
Dental · 286d
Cleared Jul 09, 2018
Straumann Jason Membrane
K173562 · NPL
Institut Straumann AG
Dental · 234d
Cleared Jul 03, 2018
Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
K172952 · EBF
Figaro Crowns, Inc.
Dental · 280d
Cleared Jun 30, 2018
Zuga Dental Implant System
K171197 · DZE
Zuga Medical, Inc.
Dental · 432d
Cleared Jun 28, 2018
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE,...
K180562 · EBG
Zirkonzahn GmbH
Dental · 115d
Cleared Jun 28, 2018
KJ ZIRCONIA Implant System
K173116 · DZE
Kj Meditech Co., Ltd.
Dental · 272d
Cleared Jun 26, 2018
Express 4 Sleep appliance/CPAP Sidekick appliance
K173856 · LRK
Moses Appliances, LLC
Dental · 188d
Cleared Jun 22, 2018
MIS Internal Hex Dental Implant System
K180282 · DZE
Mis Implants Technologies , Ltd.
Dental · 142d
Cleared Jun 19, 2018
Surgic Pro, Surgic Pro+
K173905 · EBW
Nakanishi, Inc.
Dental · 179d
Cleared Jun 18, 2018
Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral...
K181484 · EBF
Zirkonzahn Srl
Dental · 13d
Cleared Jun 18, 2018
IU Implant System
K172345 · DZE
Warantec Co., Ltd.
Dental · 320d
Cleared Jun 15, 2018
DESS Dental Smart Solutions
K173908 · NHA
Terrats Medical SL
Dental · 175d
Cleared Jun 13, 2018
Signature Orthodontic System
K181271 · NJM
Signature Orthodontics
Dental · 30d
Cleared Jun 13, 2018
PEAK NS033CF, PEAK NS017CF
K180565 · ELW
Neosil Co., Ltd.
Dental · 100d
Cleared Jun 12, 2018
ZQuiet
K180124 · LRK
Sleeping Well, LLC
Dental · 147d