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
4465–4488 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Feb 07, 2008
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
K080240 · EFB
Promident, LLC
Dental · 7d
Cleared Feb 06, 2008
ATLAS IMPLANT SYSTEM
K071148 · DZE
Cowellmedi Co., Ltd.
Dental · 288d
Cleared Feb 06, 2008
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
K073224 · EFW
Procter & Gamble
Dental · 83d
Cleared Feb 06, 2008
PSL BIOZIR BLOCK
K073568 · EIH
P.S.L. International, Inc.
Dental · 48d
Cleared Feb 06, 2008
DENFIL ETCHANT-37
K080265 · EBF
Vericom Co., Ltd.
Dental · 5d
Cleared Feb 06, 2008
WELL-PEX
K080266 · KIF
Vericom Co., Ltd.
Dental · 5d
Cleared Feb 04, 2008
MS SYSTEM (DENTURE)
K072959 · DZE
Osstem Implant Co., Ltd.
Dental · 108d
Cleared Feb 04, 2008
STATMATIC 31 HANDPIECE MAINTENANCE UNIT
K073319 · EFB
Scican , Ltd.
Dental · 70d
Cleared Feb 04, 2008
NEUN
K073554 · EBF
Heraeus Kulzer,GmbH
Dental · 48d
Cleared Jan 31, 2008
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
K072363 · DZE
Biomet 3i, Inc.
Dental · 161d
Cleared Jan 31, 2008
PROVISA CEM
K073539 · EMB
Cavex Holland BV
Dental · 45d
Cleared Jan 30, 2008
SOMNOMED BFLEX
K073004 · LRK
Somnomed, Inc.
Dental · 98d
Cleared Jan 29, 2008
MAXCEM 2
K073209 · MZW
Kerr Corporation
Dental · 76d
Cleared Jan 28, 2008
AXIS SYSTEM
K072989 · EFB
Dentsply Intl., Inc.
Dental · 97d
Cleared Jan 25, 2008
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
K072754 · EFB
Axenic Dental, Inc.
Dental · 120d
Cleared Jan 25, 2008
ORTHO ANCHOR SCREWS
K073461 · OAT
Mis Implants Technologies , Ltd.
Dental · 46d
Cleared Jan 24, 2008
IMPLASA-HOECHST GMBH IMPLANTS
K071240 · DZE
Implasa-Hoechst GmbH
Dental · 266d
Cleared Jan 23, 2008
SELF-ADHESIVE RESIN CEMENT
K073173 · EMA
Dentsply Interntional
Dental · 71d
Cleared Jan 22, 2008
SYNOCTA ABUTMENTS
K073628 · NHA
Straumann USA
Dental · 27d
Cleared Jan 17, 2008
TENDER ORTHO BOND-ENA BOND-ENA ETCH
K072978 · DYH
Micerium S.P.A.
Dental · 87d
Cleared Jan 17, 2008
AURAVENEER CEMENT
K073101 · EMA
Denali Corporation
Dental · 93d
Cleared Jan 17, 2008
GILB-2, GLASS IONOMER PROTECTIVE COATING
K073395 · EMA
3M Espe Dental Products
Dental · 45d
Cleared Jan 14, 2008
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
K072917 · DZE
Odontit S.A.
Dental · 94d
Cleared Jan 11, 2008
NOBELREPLACE HEXAGONAL IMPLANT
K073142 · DZE
Nobel Biocare USA, LLC
Dental · 65d