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
2545–2568 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 07, 2016
Tellos ISQ Buddy
K143445 · EKX
Tellos Medical AB
Dental · 401d
Cleared Dec 31, 2015
Ascent 3D
K150585 · EBZ
CAO Group, Inc.
Dental · 297d
Cleared Dec 30, 2015
VITA VM LC Flow
K152373 · EBF
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 131d
Cleared Dec 30, 2015
MedActive Oral Gel and Spray
K152201 · LFD
Medactive Oral Pharmaceuticals, LLC
Dental · 146d
Cleared Dec 23, 2015
SalivaMAX
K152406 · LFD
Forward Science, LLC
Dental · 120d
Cleared Dec 18, 2015
TRI Dental Implant System
K151916 · DZE
Tri Dental Implants Int. AG
Dental · 158d
Cleared Dec 16, 2015
Resolve 2.0
K152322 · PME
Denali Corporation
Dental · 121d
Cleared Dec 16, 2015
Zenostar MT, Zenostar Color Liquids
K152118 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 139d
Cleared Dec 11, 2015
VINTAGE Art LF
K152451 · EIH
Shofu Dental Corporation
Dental · 105d
Cleared Dec 10, 2015
Biomet Microfixation OmniMax MMF System
K152326 · JEY
Biomet Microfixation
Dental · 114d
Cleared Dec 10, 2015
BRX PRO Bruxism Guard
K151933 · MQC
12th Man Technologies, Inc.
Dental · 149d
Cleared Dec 10, 2015
BEAUTIFIL II Enamel
K151699 · EBF
Shofu Dental Corporation
Dental · 169d
Cleared Dec 10, 2015
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
K150079 · NPM
Nibec Co., Ltd.
Dental · 329d
Cleared Dec 10, 2015
OneQ-SL Implant System
K142313 · DZE
Dentis Co., Ltd.
Dental · 478d
Cleared Dec 09, 2015
One Coat 7 Universal
K152243 · KLE
Coltene/Whaledent AG
Dental · 121d
Cleared Dec 08, 2015
High Speed Handpieces and Accessories
K152146 · EFB
Codent Technical Industry Co., Ltd.
Dental · 127d
Cleared Dec 07, 2015
Respire Blue Series-EF
K152292 · LRK
Respire Medical Holding
Dental · 116d
Cleared Dec 04, 2015
Upcera Dental Zirconia Blank for Aesthetic Restoration
K152175 · EIH
Liaoning Upcera Co., Ltd.
Dental · 122d
Cleared Dec 01, 2015
Biodenta Customized Abutment - Titanium
K151295 · NHA
Biodenta Swiss AG
Dental · 200d
Cleared Nov 30, 2015
Vonflex S Putty
K152518 · ELW
Vericom Co., Ltd.
Dental · 88d
Cleared Nov 25, 2015
Avex CX2
K152779 · NJM
Opal Orthodontics by Ultradent Products
Dental · 61d
Cleared Nov 25, 2015
OT EQUATOR
K142211 · NHA
Rhein 83 Srl
Dental · 470d
Cleared Nov 24, 2015
LUXATOR LX HANDPIECE
K133178 · EGS
Directa AB
Dental · 768d
Cleared Nov 23, 2015
Star+ VPS Scannable Impression Material
K152349 · ELW
Danville Materials, LLC
Dental · 95d