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
4801–4824 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 28, 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
K062812 · EFB
Thunder Tiger Corp.
Dental · 70d
Cleared Nov 28, 2006
AURORA
K063003 · EBZ
Parkell, Inc.
Dental · 57d
Cleared Nov 28, 2006
REGEN BIOCEMENT
K063010 · LYC
Steiner Laboratories
Dental · 57d
Cleared Nov 27, 2006
MOUTHGUARD AND ALIGNER MATERIALS
K062828 · MQC
Dentsply Intl., Inc.
Dental · 68d
Cleared Nov 22, 2006
BIOHORIZONS CERAMIC ABUTMENT
K061567 · NHA
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Nov 22, 2006
RETENTION FLOW OPAQUE
K062515 · EBF
Heraeus Kulzer,GmbH
Dental · 86d
Cleared Nov 21, 2006
THE 5.0 X 6.0MM DENTAL IMPLANT
K062044 · DZE
Bicon, Inc.
Dental · 125d
Cleared Nov 21, 2006
ENAMEL PRO
K062166 · EJR
Premier Dental Products Co.
Dental · 116d
Cleared Nov 21, 2006
ENAMEL PRO VARNISH
K062683 · LBH
Premier Dental Products Co.
Dental · 74d
Cleared Nov 21, 2006
BIOAGGREGATE
K063422 · KIF
Innovative Bioceramix, Inc.
Dental · 8d
Cleared Nov 17, 2006
LAVA SOFTWARE
K062493 · NHA
3M Espe AG Dental Products
Dental · 84d
Cleared Nov 17, 2006
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
K062851 · MQN
Osteomed LP
Dental · 53d
Cleared Nov 17, 2006
ENA HFO COMPOSITE SYSTEM
K062906 · EBF
Micerium S.P.A.
Dental · 51d
Cleared Nov 16, 2006
IMPRESSIX, COLORCHANGE ALGINATE
K062400 · ELW
Cavex Holland BV
Dental · 92d
Cleared Nov 15, 2006
RIVA LUTING PLUS
K062065 · EMA
Southern Dental Industries, Inc.
Dental · 118d
Cleared Nov 15, 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
K063302 · EIA
Shanghai Dental Instrument Factory
Dental · 14d
Cleared Nov 09, 2006
RIVA BOND LC
K062064 · EMA
Southern Dental Industries, Inc.
Dental · 112d
Cleared Nov 09, 2006
TOMAS PIN SD 6, 8, AND 10 MM
K062733 · OAT
Dentaurum
Dental · 57d
Cleared Nov 08, 2006
K-ETCHANT GEL
K062409 · EBF
Kuraray Medical, Inc.
Dental · 83d
Cleared Nov 06, 2006
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · EBC
CAO Group, Inc.
Dental · 41d
Cleared Nov 02, 2006
US SYSTEM
K062030 · DZE
Osstem Implant Co., Ltd.
Dental · 107d
Cleared Nov 02, 2006
GRANDIO FLOW TRY-IN
K062343 · EBF
Voco GmbH
Dental · 83d
Cleared Nov 02, 2006
ADHESIVE DC ACTIVATOR
K062713 · KLE
Ivoclar Vivadent, Inc.
Dental · 52d
Cleared Nov 02, 2006
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
K062740 · EFB
Jindell Medical Instruments Co., Ltd.
Dental · 50d