Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Dental ×
12,659 results
1777–1800 of 12,659
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