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
7825–7848 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 04, 1996
QUANTEC SERIES 2000 ENDODONTIC FILES
K962031 · EKS
Tycom Dental
Dental · 11d
Cleared May 31, 1996
TONGUE CLEANER
K961660 · LCN
Jack Conrey
Dental · 31d
Cleared May 30, 1996
LIFE AND LIFE FAST SET
K961708 · EJK
Sybron Dental Specialties, Inc.
Dental · 28d
Cleared May 29, 1996
STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200
K960956 · EJT
Sterngold/Implamed
Dental · 79d
Cleared May 28, 1996
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
K961291 · EIH
Dentsply Intl.
Dental · 54d
Cleared May 24, 1996
OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL...
K960022 · DZE
Opti-Max
Dental · 143d
Cleared May 24, 1996
IMZ MEMBRANE TACK SYSTEM
K960945 · DZL
Interpore Intl.
Dental · 77d
Cleared May 24, 1996
BOSWORTH CH I
K961198 · EBG
Harry J. Bosworth Co.
Dental · 58d
Cleared May 24, 1996
GC FUJI ORTHO
K961417 · DYH
GC America, Inc.
Dental · 42d
Cleared May 24, 1996
FUJI II LC (IMPROVED)
K961584 · EMA
GC America, Inc.
Dental · 30d
Cleared May 23, 1996
SUPRASSON P5 BOOSTER
K961158 · ELC
Satelec
Dental · 62d
Cleared May 20, 1996
VICRYL PERIDONTAL MESH
K955646 · NPK
Ethicon, Inc.
Dental · 160d
Cleared May 20, 1996
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
K955703 · KIF
Neodental Chemical Products Co., Ltd.
Dental · 158d
Cleared May 20, 1996
SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
K960979 · DZE
Steri-Oss, Inc.
Dental · 70d
Cleared May 20, 1996
285 SL
K961352 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared May 17, 1996
BOSWORTH LIQUID RESIN II
K961200 · EBI
Harry J. Bosworth Co.
Dental · 51d
Cleared May 17, 1996
BOSWORTH IMPRESSION MATERIAL II
K961201 · ELW
Harry J. Bosworth Co.
Dental · 51d
Cleared May 16, 1996
KETAC-MOLAR APLICAP
K960954 · EMA
Espe GmbH & Co. Kg.
Dental · 66d
Cleared May 14, 1996
ABUTMENT SELECTION KIT
K960639 · DZE
Nobelpharma USA, Inc.
Dental · 90d
Cleared May 10, 1996
SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD....
K960889 · ELC
San Diego Swiss Machining, Inc.
Dental · 67d
Cleared May 09, 1996
OSAP
K960673 · LQZ
Snorefree, Inc.
Dental · 79d
Cleared May 09, 1996
ORTHO-ICE
K960799 · EAT
Ultimate Wireforms, Inc.
Dental · 72d
Cleared May 08, 1996
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K960556 · EIA
Scitech Solutions, Inc.
Dental · 89d
Cleared May 08, 1996
KOLOR +
K961284 · EBF
Sybron Dental Specialties, Inc.
Dental · 65d