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
4825–4848 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 01, 2006
SS SYSTEM
K062051 · DZE
Osstem Implant Co., Ltd.
Dental · 105d
Cleared Nov 01, 2006
PRIMACONNEX CERAMIC ABUTMENTS
K062876 · NHA
Lifecore Biomedical, Inc.
Dental · 36d
Cleared Oct 27, 2006
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
K060889 · KIF
Pentron Clinical Technologies
Dental · 210d
Cleared Oct 27, 2006
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
K062653 · LFD
Parnell Pharmaceuticals, Inc.
Dental · 50d
Cleared Oct 27, 2006
TUTU 7, MODEL IV-T22
K062735 · EBZ
Invisible Technology Co., Ltd.
Dental · 44d
Cleared Oct 26, 2006
CST61 HIGH SPEED TURBINE HANDPIECE
K063110 · EFB
Shanghai Dental Instrument Factory
Dental · 15d
Cleared Oct 25, 2006
UNICEM
K062292 · EMA
3M Espe Dental Products
Dental · 79d
Cleared Oct 25, 2006
TOMAS PIN 6 MM
K062732 · OAT
Dentaurum
Dental · 42d
Cleared Oct 20, 2006
P.0004 IMPLANTS
K062129 · DZE
Institut Straumann AG
Dental · 86d
Cleared Oct 20, 2006
SUPER ORTHODONTIC SCREW
K062156 · DZE
Osstem Implant Co., Ltd.
Dental · 84d
Cleared Oct 20, 2006
SAGEMAX Z-BLANK
K062695 · EIH
Sagemax Bioceramics, Inc.
Dental · 39d
Cleared Oct 19, 2006
K-SPRAY, MODEL 085-2715
K062418 · EFB
Scican
Dental · 62d
Cleared Oct 19, 2006
NEXUS 3
K062519 · EMA
Kerr Corporation
Dental · 52d
Cleared Oct 18, 2006
DENSHIELD TREATMENT FOR SENSITIVE TEETH
K061359 · LBH
Novamin Technology, Inc.
Dental · 155d
Cleared Oct 18, 2006
CLARITY MODIFIED CERAMIC BRACKETS
K062305 · NJM
3M Unitek
Dental · 71d
Cleared Oct 17, 2006
POWERTOME PERIOTOME
K063007 · EKX
Westport Medical, Inc.
Dental · 15d
Cleared Oct 13, 2006
CONFORM
K062157 · EBF
Apex Dental Materials, Inc.
Dental · 77d
Cleared Oct 13, 2006
COLLAGEN DENTAL MEMBRANE III
K062846 · NPL
Collagen Matrix, Inc.
Dental · 21d
Cleared Oct 12, 2006
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
K061847 · NHA
Zimmer Dental, Inc.
Dental · 104d
Cleared Oct 11, 2006
COLLAGEN DENTAL MENBRANE - CONFORMABLE II
K062881 · NPL
Collagen Matrix, Inc.
Dental · 15d
Cleared Oct 06, 2006
ZERION ALPHA,
K061804 · EIH
Etkon International GmbH
Dental · 101d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997 · EBC
Premier Dental Products Co.
Dental · 82d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING BOND ENHANCER
K061998 · KLE
Premier Dental Products Co.
Dental · 82d
Cleared Oct 02, 2006
GRANDIO SEAL
K062344 · EBC
Voco GmbH
Dental · 52d