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
1561–1584 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 22, 2020
FAICO CMF System
K191997 · JEY
Faico Medical, LLC
Dental · 271d
Cleared Apr 21, 2020
DIBS (Digital Indirect Bonding System)
K192701 · PNN
Orthoselect, LLC
Dental · 207d
Cleared Apr 17, 2020
BRUIS Software Suite
K191720 · PNN
Mechanodontics, Inc.
Dental · 295d
Cleared Apr 16, 2020
DD Contrast
K193588 · EIH
Dental Direkt GmbH
Dental · 115d
Cleared Apr 13, 2020
s-Clean SQ-SL Implant System Mini
K200099 · DZE
Dentis Co., Ltd.
Dental · 88d
Cleared Apr 10, 2020
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
K190353 · PLC
Residential Home Sleep Services
Dental · 420d
Cleared Apr 08, 2020
Panthera Dental Milled Bars
K192108 · NHA
Panthera Dental, Inc.
Dental · 247d
Cleared Apr 06, 2020
Straumann Screw-Retained Abutments
K192401 · NHA
Straumann USA, LLC
Dental · 216d
Cleared Apr 03, 2020
Faico Dental Implant System
K192015 · DZE
Faico Medical, LLC
Dental · 249d
Cleared Apr 02, 2020
CS Model+
K193390 · PNN
Trophy
Dental · 118d
Cleared Apr 01, 2020
DSI Dental Implant System
K200188 · DZE
Dsi Dental Solutions, Ltd.
Dental · 68d
Cleared Mar 30, 2020
Universal Base Conical Connection (CC)
K200040 · NHA
Nobel Biocare AG
Dental · 82d
Cleared Mar 27, 2020
GrandioSO Light Flow
K200294 · EBF
Voco GmbH
Dental · 51d
Cleared Mar 27, 2020
Diapaste
K190091 · KIF
DiaDent Group International
Dental · 434d
Cleared Mar 26, 2020
Stryker Facial iD Plating System
K193143 · JEY
Stryker
Dental · 134d
Cleared Mar 26, 2020
Stryker Customized Mandible Recon Plate Kit
K193136 · JEY
Stryker
Dental · 134d
Cleared Mar 25, 2020
MIS CONNECT Conical Connection System
K193078 · NHA
Dentsply Sirona
Dental · 141d
Cleared Mar 25, 2020
DiaFil Flow
K192284 · EBF
DiaDent Group International
Dental · 216d
Cleared Mar 24, 2020
Sherlock
K193335 · NHA
Open Implants, LLC
Dental · 113d
Cleared Mar 20, 2020
iTero Element 5D
K193659 · NTK
Align Technology, Inc.
Dental · 81d
Cleared Mar 20, 2020
DIAFIL & DIAFIL Capsule
K192510 · EBF
DiaDent Group International
Dental · 190d
Cleared Mar 20, 2020
Clearform Aligners
K191838 · NXC
Motor City Lab Works
Dental · 255d
Cleared Mar 17, 2020
TheraBase, TheraBase Ca
K192007 · EMA
Bisco, Inc.
Dental · 232d
Cleared Mar 16, 2020
AnatomicAligner
K190767 · LLZ
The Methodist Hospital Research...
Dental · 357d