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
4345–4368 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 01, 2008
STRESSGARD NIGHTGUARD
K072968 · OBR
Totalgard Corporation
Dental · 253d
Cleared Jul 01, 2008
STARCERAM
K081263 · EIH
H.C. Starck Ceramics GmbH & Co.Kg
Dental · 57d
Cleared Jun 20, 2008
SMARTBURS
K080687 · EJL
S.S. White Burs, Inc.
Dental · 101d
Cleared Jun 19, 2008
ESTELITE SIGMA QUICK
K080940 · EBF
Tokuyama Dental Corporation
Dental · 77d
Cleared Jun 12, 2008
ENDSNOR
K072731 · LRK
Dockstader Orthodontic Lab, Inc.
Dental · 260d
Cleared Jun 11, 2008
RESICEM
K080517 · EMA
Shofu Dental Corp.
Dental · 107d
Cleared Jun 11, 2008
GC OPB-100
K080724 · DYH
GC America, Inc.
Dental · 89d
Cleared Jun 11, 2008
VINTAGE ART
K080834 · EIH
Shofu Dental Corp.
Dental · 78d
Cleared Jun 06, 2008
ZIRKONDENT
K080146 · EIH
Ergometa
Dental · 136d
Cleared Jun 06, 2008
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
K080677 · EIA
Kaltenbach & Voigt GmbH & Co.
Dental · 88d
Cleared Jun 05, 2008
GRADIA FORTE
K080478 · EBF
GC America, Inc.
Dental · 104d
Cleared Jun 03, 2008
BONEMEDIK-DM
K080772 · LYC
Meta Biomed Co., Ltd.
Dental · 76d
Cleared May 30, 2008
MUCOGRAFT COLLAGEN MATRIX
K073711 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 151d
Cleared May 30, 2008
I-MINI DENTAL IMPLANT
K080115 · DZE
Oco Biomedical
Dental · 135d
Cleared May 30, 2008
SECURE IMPLANT SYSTEM (2.5/3.0MM)
K080129 · DZE
Dio Department Dsi, Inc.
Dental · 134d
Cleared May 30, 2008
NANOCOMPOSITE RESTORATIVE KIT
K080480 · EBF
Dmg USA, Inc.
Dental · 98d
Cleared May 23, 2008
CLEANSE.FRESHEN.GO
K080631 · EFT
Oral Health Technologies, LLC
Dental · 79d
Cleared May 23, 2008
CONCAVE RN HEALING CAP
K081186 · NHA
Institut Straumann AG
Dental · 25d
Cleared May 22, 2008
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
K081291 · DYH
Dentsply Interntional
Dental · 15d
Cleared May 21, 2008
DENTAL CERAMIC
K080479 · EIH
Dmg USA, Inc.
Dental · 89d
Cleared May 21, 2008
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
K080598 · NHA
Intra-Lock International
Dental · 79d
Cleared May 16, 2008
DIO BIOTITE-H IMPLANT SYSTEM
K073070 · DZE
Dio Department Dsi, Inc.
Dental · 199d
Cleared May 16, 2008
REACTIVE DENTAL IMPLANT SYSTEM
K080713 · DZE
Implant Direct, LLC
Dental · 64d
Cleared May 15, 2008
OSTEOMED MODULAR LOCKING FIXATION SYSTEM
K080694 · JEY
Osteomed LP
Dental · 65d