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
1897–1920 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 29, 2018
Implant-One System
K173701 · DZE
Implant Logistics, Inc.
Dental · 360d
Cleared Nov 28, 2018
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
K181604 · ELW
Hrs Co., Ltd.
Dental · 162d
Cleared Nov 26, 2018
3M Clarity Aligners
K183159 · NXC
3M Company
Dental · 11d
Cleared Nov 26, 2018
Orchestrate 3D
K181112 · PNN
Orchestrate 3D
Dental · 213d
Cleared Nov 23, 2018
A.B. Dental Devices Dental Implants System
K181381 · NHA
A.B. Dental Device , Ltd.
Dental · 183d
Cleared Nov 21, 2018
ApnoDent Appliance
K181123 · LRK
Apnomed, Inc.
Dental · 205d
Cleared Nov 20, 2018
TPH Spectra ST Flowable Composite Restorative
K182288 · EBF
Dentsply Sirona
Dental · 89d
Cleared Nov 20, 2018
GC Acrylic Primer
K180917 · KLE
GC America, Inc.
Dental · 225d
Cleared Nov 16, 2018
Oral Device OA, Oral Device S
K181396 · LRK
Passion For Life Healthcare (Uk) Limited
Dental · 171d
Cleared Nov 16, 2018
IT-III active System
K181137 · DZE
Neobiotech Co., Ltd.
Dental · 200d
Cleared Nov 16, 2018
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
K180184 · NHA
Dentalpoint AG
Dental · 297d
Cleared Nov 15, 2018
Nexcomp
K181689 · EBF
Meta Biomed Co., Ltd.
Dental · 142d
Cleared Nov 15, 2018
K2 Zirkon Blank white classic
K173971 · EIH
Yeti Dentalprodukte GmbH
Dental · 321d
Cleared Nov 14, 2018
Inversa Implants
K181850 · DZE
Southern Implants (Pty), Ltd.
Dental · 126d
Cleared Nov 14, 2018
Apoller Flow Light Cure Flowable Composite
K180463 · EBF
Greenway Yw, LLC
Dental · 266d
Cleared Nov 09, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · DYW
Blue Sky Bio
Dental · 73d
Cleared Nov 08, 2018
SureCure Orthodontic Aligner System
K182329 · NXC
Digital Orthodontic Care
Dental · 72d
Cleared Nov 07, 2018
OptiBond eXTRa Universal
K182162 · KLE
Kerr Corporation
Dental · 89d
Cleared Nov 06, 2018
SaliPen
K180838 · LTF
Saliwell , Ltd.
Dental · 221d
Cleared Nov 06, 2018
W Zirconia Implants
K172668 · DZE
Tav Medical , Ltd.
Dental · 427d
Cleared Nov 01, 2018
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
K181266 · DZE
Novodent SA
Dental · 171d
Cleared Oct 31, 2018
Universal Base Abutment
K180899 · NHA
Nobel Biocare AB
Dental · 208d
Cleared Oct 31, 2018
LUXEN Zr, LUXEN Smile
K171585 · EIH
Dentalmax Co., Ltd.
Dental · 518d
Cleared Oct 30, 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · DYW
Tomy, Inc.
Dental · 225d