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
7585–7608 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 11, 1997
SOOTHING WATER-FILLED TEETHER
K965082 · KKO
Consolidated Stores Corp.
Dental · 82d
Cleared Mar 11, 1997
INTRAORAL MANDIBULAR DISTRACTION DEVICE
K970256 · JEY
Medicon EG
Dental · 47d
Cleared Mar 05, 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · DZE
Steri-Oss, Inc.
Dental · 134d
Cleared Mar 05, 1997
STERILE WATER PUMP
K970002 · EIA
Micro Motors, Inc.
Dental · 62d
Cleared Mar 05, 1997
AUROFLUID 22
K970044 · EJS
Metalor Dental USA Corp.
Dental · 58d
Cleared Mar 05, 1997
SOLARO 33
K970045 · EJS
Metalor Dental USA Corp.
Dental · 58d
Cleared Mar 04, 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · DZE
Dentsply Intl.
Dental · 146d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM
K963495 · DZE
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - SCREW
K963522 · DZE
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860 · EBW
Bell Intl., Inc.
Dental · 89d
Cleared Feb 28, 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL...
K964863 · EBW
Bell Intl., Inc.
Dental · 86d
Cleared Feb 27, 1997
ARGI-SATIN OR OPTI0-STAR
K965216 · ELL
Argen Precious Metals, Inc.
Dental · 59d
Cleared Feb 27, 1997
3M QUIKPLUS SYSTEM
K970168 · EBG
3M Company
Dental · 42d
Cleared Feb 26, 1997
SPETEMP
K964808 · EMA
Ultradent Products, Inc.
Dental · 89d
Cleared Feb 25, 1997
PERFECTIM
K964692 · ELW
J. Morita USA, Inc.
Dental · 95d
Cleared Feb 25, 1997
THREADLOC DENTAL IMPLANT SYSTEMS
K964768 · DZE
Sulzer Calcitek, Inc.
Dental · 90d
Cleared Feb 25, 1997
LIFECORE CONICAL ABUTMENT
K965135 · DZE
Lifecore Biomedical, Inc.
Dental · 64d
Cleared Feb 21, 1997
DENTEMP ONE STEP
K964773 · EMA
Majestic Drug Co., Inc.
Dental · 86d
Cleared Feb 14, 1997
DENTINSENSE B/C
K965138 · KLE
Centrix, Inc.
Dental · 53d
Cleared Feb 11, 1997
STERI-OSS GOLD ATTACHMENT SYSTEM
K963945 · DZE
Steri-Oss, Inc.
Dental · 132d
Cleared Feb 10, 1997
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
K962576 · DZE
Calcitek, Inc.
Dental · 224d
Cleared Feb 10, 1997
MINERAL TRIOXIDE AGGREGATE (MTA)
K964174 · KIF
Tulsa Dental Products, Ltd.
Dental · 115d
Cleared Feb 10, 1997
TEFGEN GUIDED TISSUE MEMBRANE
K964656 · NPK
American Custom Medical, Inc.
Dental · 82d
Cleared Feb 10, 1997
DERMADAM
K964810 · EFS
Ultradent Products, Inc.
Dental · 73d