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
1489–1512 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 17, 2020
Cytrans Granules
K192597 · LYC
GC America, Inc.
Dental · 332d
Cleared Aug 16, 2020
Sirona Dental CAD/CAM System with CEREC Chairside Software
K193408 · NHA
Dentsply Sirona
Dental · 251d
Cleared Aug 14, 2020
BracePaste Band and Build LC
K202276 · DYH
American Orthodontics
Dental · 3d
Cleared Aug 14, 2020
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill...
K201010 · EBF
Nobio , Ltd.
Dental · 119d
Cleared Aug 14, 2020
LOOP LED Curing Light System
K200775 · EBZ
Garrison Dental Solutions, LLC
Dental · 142d
Cleared Aug 14, 2020
Orthocem, Ortho Bite
K192682 · DYH
Dentscare Ltda
Dental · 323d
Cleared Aug 13, 2020
Straumann® Retentive System – Novaloc TiN Abutments
K193046 · NHA
Institut Straumann AG
Dental · 286d
Cleared Aug 11, 2020
Disposable High Speed Air Turbine Handpiece
K193264 · EFB
Ningbo Hpdove Dental Instruments Co.,...
Dental · 259d
Cleared Aug 07, 2020
D-LUX+
K200809 · EBZ
DiaDent Group International
Dental · 133d
Cleared Aug 07, 2020
MVP Aligner System
K193130 · NXC
Mvp Aligners, LLC
Dental · 269d
Cleared Jul 31, 2020
P pro Crown & Bridge
K200039 · EBG
Deltamed GmbH
Dental · 205d
Cleared Jul 31, 2020
I Do
K192294 · DZE
I DO Biotech Co., Ltd.
Dental · 343d
Cleared Jul 31, 2020
Flex Fit
K190790 · EBI
Dk Mungyo Corporation
Dental · 492d
Cleared Jul 29, 2020
BoniPlus Dental G-Mesh System
K182759 · JEY
Montjade Engineering Co., Ltd.
Dental · 670d
Cleared Jul 28, 2020
Neocis Guidance System (NGS) with Patient Splints
K200805 · PLV
Neocis, Inc.
Dental · 123d
Cleared Jul 22, 2020
Duranext Abutments
K200355 · NHA
Elegant Dental Corp.
Dental · 160d
Cleared Jul 21, 2020
VITA LUMEX AC
K193434 · EIH
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 223d
Cleared Jul 21, 2020
AUTOLIGN
K192847 · PNN
Diorco Co., Ltd.
Dental · 292d
Cleared Jul 15, 2020
Magicore II System
K201621 · NHA
Innobiosurg Co., Ltd.
Dental · 30d
Cleared Jul 13, 2020
TRAUS SUS20
K192561 · DZI
Saeshin Precision Co., Ltd.
Dental · 300d
Cleared Jul 09, 2020
GC Temp Print
K193113 · EBG
GC America, Inc.
Dental · 240d
Cleared Jul 08, 2020
VisCalor
K201307 · EBF
Voco GmbH
Dental · 54d
Cleared Jul 08, 2020
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
K200676 · EBG
Zirkonzahn Srl
Dental · 114d
Cleared Jul 08, 2020
Dental Glass Ceramics Blocks
K192231 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 327d