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
1945–1968 of 12,659
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