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
6577–6600 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 23, 2000
BIOSOFT RESIN
K001640 · EBI
Biosoft International Corp.
Dental · 46d
Cleared Jun 21, 2000
MEMOGRAPH
K001219 · JEY
Biomedical Ent., Inc.
Dental · 65d
Cleared Jun 21, 2000
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
K001269 · EJH
Dentalmatic Technologies, Inc.
Dental · 62d
Cleared Jun 21, 2000
PALCERAM 53
K001479 · EJT
Aurex SA (Pty) , Ltd.
Dental · 41d
Cleared Jun 21, 2000
AURECAST 40 B
K001480 · EJT
Aurex SA (Pty) , Ltd.
Dental · 41d
Cleared Jun 21, 2000
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
K001786 · DZE
Sulzer Calcitek, Inc.
Dental · 8d
Cleared Jun 20, 2000
SIGNUM
K001360 · EBF
J.F. Jelenko & Co., Inc.
Dental · 53d
Cleared Jun 20, 2000
AURELUX Y 84 PREMIUM
K001477 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
AURECAST SUPER INLAY
K001478 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 16, 2000
TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
K000996 · EFT
Dentsply Intl.
Dental · 80d
Cleared Jun 16, 2000
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
K001463 · EBI
Davis Schottlander & Davis, Ltd.
Dental · 37d
Cleared Jun 15, 2000
MACH 7
K990060 · KOJ
Kreativ, Inc.
Dental · 524d
Cleared Jun 13, 2000
CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
K000981 · EJH
C-Mix
Dental · 78d
Cleared Jun 13, 2000
HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
K001309 · EBG
Kay See Dental Mfg. Co.
Dental · 49d
Cleared Jun 09, 2000
MULTI ADJUSTABLE FACE MASK
K000358 · DZB
Ortho Technology
Dental · 126d
Cleared Jun 09, 2000
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114 · EBG
3M Company
Dental · 64d
Cleared Jun 08, 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · JEY
Bionx Implants, Inc.
Dental · 86d
Cleared Jun 08, 2000
AIRDENT II CS
K001313 · KOJ
Air Technologies, Inc.
Dental · 43d
Cleared May 30, 2000
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
K001108 · EBF
Prime Dental Manufacturing, Inc.
Dental · 55d
Cleared May 25, 2000
SYNTHETIC GLASS BONE GRAFT MATERIAL
K000633 · LYC
Blue Sky Bio
Dental · 90d
Cleared May 25, 2000
VISION ESTHETIC PORCELAIN SYSTEM
K000680 · EIH
Midatlantic Division of Dentrex, Inc.
Dental · 86d
Cleared May 25, 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · ELW
Cavex Holland BV
Dental · 86d
Cleared May 23, 2000
AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED,...
K001041 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 53d
Cleared May 19, 2000
C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3,...
K000894 · EBG
Dental Ventures of America, Inc.
Dental · 60d