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
1729–1752 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 30, 2019
SmileAlign Orthodontic Aligner System
K191774 · NXC
3D Global Biotech, Inc.
Dental · 90d
Cleared Sep 30, 2019
UF(II) Anatomic abutment
K190048 · NHA
Dio Corporation
Dental · 263d
Cleared Sep 29, 2019
Visalys Tooth Primer
K191524 · KLE
Kettenbach GmbH & Co. KG
Dental · 111d
Cleared Sep 27, 2019
CEREC Guides
K190059 · NDP
Dentsply Sirona
Dental · 259d
Cleared Sep 26, 2019
Dia-Proseal
K182009 · KIF
DiaDent Group International
Dental · 426d
Cleared Sep 24, 2019
Novidia Universal Bond
K183391 · KLE
Nobio , Ltd.
Dental · 291d
Cleared Sep 18, 2019
OraCure
K183436 · OLR
Tbm Corporation
Dental · 281d
Cleared Sep 17, 2019
Sapphire Dorsal Comfort Fit
K181416 · LRK
Crane Dental Laboratory, Inc.
Dental · 474d
Cleared Sep 13, 2019
Infinix Universal Composite
K182921 · EBF
Nobio , Ltd.
Dental · 329d
Cleared Sep 12, 2019
OrthoAnalysis Software
K183695 · PNN
Inteware Co., Ltd.
Dental · 255d
Cleared Sep 11, 2019
TurboTemp EZ
K191619 · EBG
Zest Anchors, LLC
Dental · 85d
Cleared Sep 11, 2019
Neocis Guidance System (NGS)
K191605 · PLV
Neocis, Inc.
Dental · 86d
Cleared Sep 06, 2019
Klinly Ultrasonic Tongue Cleaner
K181986 · QIA
Kea Products, Ltd.
Dental · 408d
Cleared Sep 05, 2019
3M Clarity Aligners
K192119 · NXC
3M Company
Dental · 30d
Cleared Sep 05, 2019
SmarTemp X1
K190930 · EBG
Parkell, Inc.
Dental · 148d
Cleared Sep 04, 2019
VPS Impression Material
K191034 · ELW
Hygedent, Inc.
Dental · 139d
Cleared Sep 04, 2019
Opus Bulk Fill APS, Opus Bulk Fill Flow APS
K190758 · EBF
Dentscare Ltda
Dental · 163d
Cleared Sep 04, 2019
K3
K183347 · EIA
Osstem Implant Co., Ltd.
Dental · 275d
Cleared Aug 29, 2019
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed,...
K192042 · NPL
Geistlich Pharma AG
Dental · 29d
Cleared Aug 29, 2019
O2Vent Optima
K190236 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 204d
Cleared Aug 29, 2019
SGS Dental Implants System
K182219 · DZE
Sgs International, Ltd.
Dental · 379d
Cleared Aug 26, 2019
Halley resin system
K191427 · EBI
Dentsply Sirona
Dental · 89d
Cleared Aug 26, 2019
IPS e.max CAD Abutment Solutions- extra systems
K191382 · NHA
Ivoclar Vivadent, AG
Dental · 95d
Cleared Aug 23, 2019
OSW Aligner System
K191990 · NXC
Osw Manufacturing, LLC
Dental · 29d