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
2017–2040 of 12,659
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