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
6313–6336 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 27, 2001
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
K012060 · ELC
Hu-Friedy Mfg. Co., Inc.
Dental · 25d
Cleared Jul 27, 2001
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
K990667 · NEI
KLS-Martin L.P.
Dental · 878d
Cleared Jul 23, 2001
ISODAN
K010415 · KLE
Specialites Septodont
Dental · 161d
Cleared Jul 23, 2001
TOOTH SHADE RESIN MATERIAL
K011453 · EBF
Rite-Dent Manufacturing Corp.
Dental · 73d
Cleared Jul 23, 2001
RESTORE-X
K011520 · EMA
First Scientific Limited
Dental · 67d
Cleared Jul 19, 2001
CAVEX STABISIL
K011452 · ELW
Cavex Holland BV
Dental · 69d
Cleared Jul 18, 2001
ADMIRA FLOW
K011756 · EBF
Voco GmbH
Dental · 42d
Cleared Jul 16, 2001
CAVEX COLORCHANGE
K011419 · ELW
Cavex Holland BV
Dental · 68d
Cleared Jul 16, 2001
CONCORD 72
K011626 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 16, 2001
CONCORD 82
K011628 · EJT
Gateway Alloys, Inc.
Dental · 48d
Cleared Jul 12, 2001
HA-TI (HAND TITANIUM SCREW) IMPLANT
K003045 · DZE
Hati Dental Ag.
Dental · 286d
Cleared Jul 12, 2001
TRUBYTE DENTURE BASE RESIN SYSTEM
K011560 · EBI
Dentsply Intl.
Dental · 52d
Cleared Jul 11, 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · JEY
Macropore Biosurgery, Inc.
Dental · 355d
Cleared Jul 10, 2001
LUTE
K011517 · EBF
First Scientific Limited
Dental · 54d
Cleared Jul 05, 2001
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
K003818 · DZE
Titan Implants
Dental · 206d
Cleared Jul 05, 2001
PREMIUM
K011130 · ELM
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Jul 05, 2001
IN TEN-S
K011492 · EBF
Ivoclar North America, Inc.
Dental · 51d
Cleared Jul 03, 2001
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE...
K011032 · LYC
Harvest Technologies, Corp.
Dental · 89d
Cleared Jun 29, 2001
ZURICH DISTRACTION SYSTEM
K010139 · MQN
KLS-Martin L.P.
Dental · 163d
Cleared Jun 29, 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394 · EIH
Espe Dental AG
Dental · 53d
Cleared Jun 28, 2001
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL...
K011061 · EGS
W&H Dentalwerk Buermoos GmbH
Dental · 83d
Cleared Jun 27, 2001
RESTORE-PF VIC
K011295 · EBF
First Scientific Limited
Dental · 58d
Cleared Jun 27, 2001
MODIFICATION TO EXCITE
K011490 · KLE
Ivoclar North America, Inc.
Dental · 43d
Cleared Jun 26, 2001
HARD RELINER
K011277 · EBI
S & C Polymer GmbH
Dental · 61d