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
6505–6528 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 25, 2000
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K001493 · EFS
Air Force, Inc.
Dental · 166d
Cleared Oct 25, 2000
DIRECT CROWN
K001884 · EBG
Flexible Dimensions, LLC
Dental · 126d
Cleared Oct 25, 2000
MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
K002675 · EJT
Product Development Industries, Inc.
Dental · 58d
Cleared Oct 25, 2000
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
K003219 · ELR
Harald Nordin S.A
Dental · 9d
Cleared Oct 25, 2000
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
K003221 · ELR
Harald Nordin S.A
Dental · 9d
Cleared Oct 24, 2000
EQUITY
K002826 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Oct 20, 2000
LACTOSORB PUSH SCREW
K002423 · DZL
Biomet, Inc.
Dental · 73d
Cleared Oct 20, 2000
DURAGARD SODIUM FLUORIDE VARNISH
K002581 · LBH
Sultan Dental Products, Ltd.
Dental · 63d
Cleared Oct 19, 2000
MACROPOREMX MANDIBULAR FIXATION SYSTEM
K000696 · JEY
Macropore Biosurgery, Inc.
Dental · 232d
Cleared Oct 19, 2000
LUMALITE CURE LIGHT, MODEL 2100
K002566 · EBZ
Lumalite, Inc.
Dental · 63d
Cleared Oct 19, 2000
JEL BIOS PURE
K002645 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Oct 18, 2000
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K003090 · EIA
Midmark Corp.
Dental · 15d
Cleared Oct 13, 2000
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
K002168 · EJI
Ronvig Instruments, Ltd.
Dental · 88d
Cleared Oct 10, 2000
Q-LUX PLASMA 100 LIGHT CURE UNIT
K001719 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 127d
Cleared Oct 10, 2000
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
K002152 · MQN
KLS-Martin L.P.
Dental · 85d
Cleared Oct 05, 2000
TDK HANDPIECES
K000848 · EFB
Orasystems
Dental · 204d
Cleared Oct 05, 2000
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · JEY
Bioplate, Inc.
Dental · 20d
Cleared Sep 28, 2000
COMFORT CONTROL SYRINGE SYSTEM
K002387 · EJI
Dentsply Intl.
Dental · 55d
Cleared Sep 28, 2000
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · EMA
3M Company
Dental · 49d
Cleared Sep 27, 2000
ORALUBE
K000847 · EFB
Orasystems
Dental · 196d
Cleared Sep 26, 2000
FREEZER TEETHER
K002066 · KKO
Cool Baby, Inc.
Dental · 81d
Cleared Sep 26, 2000
SUPER 6
K002300 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
SUPER 14
K002302 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
K002461 · EMA
Shofu Dental Corp.
Dental · 47d