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
7465–7488 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 15, 1997
SEALAPEX
K972369 · KIF
Sybron Dental Specialties, Inc.
Dental · 51d
Cleared Aug 15, 1997
AALBA GOLD SOLDER
K972532 · EJT
Aalba Dent, Inc.
Dental · 39d
Cleared Aug 15, 1997
VERA PD SOLDER
K972632 · EJT
Aalba Dent, Inc.
Dental · 32d
Cleared Aug 12, 1997
IMZ TWIN PLUS SCREW
K963520 · DZE
Imz, GmbH
Dental · 343d
Cleared Aug 11, 1997
COHEN DISTRACTOR
K972154 · JEY
Howmedica Leibinger, Inc.
Dental · 63d
Cleared Aug 11, 1997
GUERRERO - BELL DISTRACTOR
K972166 · JEY
Howmedica Leibinger, Inc.
Dental · 63d
Cleared Aug 06, 1997
IMZ TWIN PLUS - CYLINDER
K963521 · DZE
Imz, GmbH
Dental · 337d
Cleared Aug 06, 1997
CYTOPLAST REGENTEX TITANIUM 250
K972278 · LYC
Osteogenics Co.
Dental · 49d
Cleared Aug 05, 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548 · LYC
Etex Corp.
Dental · 403d
Cleared Aug 01, 1997
ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING...
K972239 · ELW
Zhermack S.P.A.
Dental · 46d
Cleared Jul 24, 1997
REACH ANTIBACTERIAL TOOTHBRUSH
K971589 · EFW
Personal Products Co.
Dental · 84d
Cleared Jul 24, 1997
DENTALIS KEZ ENDODONITC SEALER
K971642 · EMA
Neodental Chemical Products Co., Ltd.
Dental · 83d
Cleared Jul 21, 1997
DINABASE (TM)
K971138 · EBI
Sultan Chemists, Inc.
Dental · 115d
Cleared Jul 21, 1997
ANTIBACTERIAL GUTTA PERCHA
K971641 · EKM
Dr. Howard Martin, P.A.
Dental · 80d
Cleared Jul 21, 1997
TIADAPT ABUTMENT SYSTEM
K971706 · NHA
Nobel Biocare Uas, Inc.
Dental · 74d
Cleared Jul 18, 1997
BREATH ACE BREATHFRESHENER
K972131 · LCN
Beyond 21st Century, Inc.
Dental · 42d
Cleared Jul 16, 1997
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT...
K972027 · ELW
Zhermack S.P.A.
Dental · 44d
Cleared Jul 15, 1997
ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
K970683 · EBF
Foremost Dental Mfg., Inc.
Dental · 141d
Cleared Jul 15, 1997
SMILE WITH CONFIDENCE
K971002 · EHS
Lloyd V. Ziemendorf
Dental · 118d
Cleared Jul 10, 1997
ACTA OEM MODULE
K972006 · EBZ
Interactive Consulting, Inc.
Dental · 41d
Cleared Jul 09, 1997
SP4044 & SP4055 LUX MODULES
K972026 · ELC
Satelec
Dental · 37d
Cleared Jul 03, 1997
BIO-ESTHETIC INDIRECT ABUTMENT
K970073 · NHA
Steri-Oss, Inc.
Dental · 176d
Cleared Jul 03, 1997
PURE COMPANY FLUID DELIVERY SYSTEM
K971278 · EIA
Pure Co.
Dental · 87d
Cleared Jul 03, 1997
PEFECT SHOT
K972019 · EIA
International Imaging Electronics
Dental · 32d