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
4225–4248 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 17, 2008
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
K083610 · EBF
3M Company
Dental · 9d
Cleared Dec 15, 2008
DISTRAX
K080542 · MQN
John W. King
Dental · 292d
Cleared Dec 12, 2008
TRIMIRA OCS 3000
K082603 · NXV
Remicalm, LLC
Dental · 95d
Cleared Dec 11, 2008
HERCULITE ULTRA
K082671 · EBF
Sybron Dental Specialties
Dental · 87d
Cleared Dec 11, 2008
BEAUTIBOND
K082744 · KLE
Shofu Dental Corp.
Dental · 84d
Cleared Dec 11, 2008
CUSTOM COMFORT NIGHTGUARD
K083400 · OBR
Den Tek Oral Care, Inc.
Dental · 24d
Cleared Dec 09, 2008
TEMPORARY COLD.V AND SELF-CURE DENTINE
K082700 · EBG
Major Prodotti Dentari S.P.A.
Dental · 85d
Cleared Dec 05, 2008
FLEXITIME BITE
K082591 · ELW
Heraeus Kulzer, Inc., Dental Products...
Dental · 88d
Cleared Dec 04, 2008
OMNI-TIGHT
K082749 · DZE
Basic Dental Implant Systems, Inc.
Dental · 76d
Cleared Dec 03, 2008
LEDEX, MODEL: WL-070
K082408 · EBZ
Dentmate Technology Co. , Ltd.
Dental · 104d
Cleared Dec 02, 2008
ZIOCERA & CONVERTIBLE SYSTEM
K081786 · NHA
Osstem Implant Co., Ltd.
Dental · 161d
Cleared Nov 26, 2008
GC AADVA ZR DISK
K082740 · EIH
GC America, Inc.
Dental · 69d
Cleared Nov 25, 2008
MAJOR.REPAIR
K082153 · EBI
Major Prodotti Dentari S.P.A.
Dental · 118d
Cleared Nov 25, 2008
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
K082200 · DZE
SOADCO, S.L.
Dental · 113d
Cleared Nov 25, 2008
ORLUS MINI SCREW
K082838 · DZE
Ortholution Co., Ltd.
Dental · 60d
Cleared Nov 24, 2008
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · KLE
Voco GmbH
Dental · 66d
Cleared Nov 21, 2008
STOMA BONE BLOCK SCREW
K080430 · DZL
Storz AM Mark GmbH
Dental · 276d
Cleared Nov 21, 2008
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
K081287 · EBZ
Den-Mat Holdings, LLC
Dental · 198d
Cleared Nov 21, 2008
TDS ABUTMENT
K081460 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 182d
Cleared Nov 20, 2008
VERICORE IMPLANT ABUTMENTS
K082299 · NHA
Whip-Mix Corp.
Dental · 100d
Cleared Nov 19, 2008
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP...
K083100 · NHA
Nobel Biocare USA, LLC
Dental · 30d
Cleared Nov 17, 2008
LANG DENTAL ACRYLIC PRIMER
K081981 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 129d
Cleared Nov 14, 2008
GDLS-200
K082434 · EBF
GC America, Inc.
Dental · 81d
Cleared Nov 13, 2008
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · DZE
BioHorizons Implant Systems, Inc.
Dental · 139d