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
1705–1728 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 16, 2019
EM Provisional
K191751 · DZE
Hiossen, Inc.
Dental · 168d
Cleared Dec 16, 2019
Llis, Vittra APS
K191306 · EBF
Dentscare Ltda
Dental · 216d
Cleared Dec 16, 2019
SunClear Aligner system
K190394 · NXC
Sun Dental Laboratories, LLC
Dental · 300d
Cleared Dec 13, 2019
Ambar, Ambar APS, Ambar Universal APS
K183424 · KLE
Dentscare Ltda
Dental · 367d
Cleared Dec 12, 2019
BIO-C Sealer Ion+
K190537 · KIF
Angelus Industria DE Produtos...
Dental · 283d
Cleared Dec 11, 2019
MIS Dental Implant System
K192149 · DZE
Dentsply Sirona, Inc.
Dental · 124d
Cleared Dec 11, 2019
SleepTight Mouthpiece STZ
K191618 · LRK
Michael D Williams Dds PA
Dental · 176d
Cleared Dec 11, 2019
EVO 450 series High Speed Handpieces
K190508 · EFB
Ttbio Corp.
Dental · 285d
Cleared Dec 09, 2019
TSV BellaTek Express and BellaTek Flex Abutments
K192522 · NHA
Biomet 3i, LLC
Dental · 87d
Cleared Dec 09, 2019
Straumann Mini Implants
K191895 · DZE
Institut Straumann AG
Dental · 147d
Cleared Dec 09, 2019
Southern Implants MAX Implant System
K191054 · DZE
Southern Implants (Pty), Ltd.
Dental · 234d
Cleared Dec 09, 2019
Dental high speed handpiece, Dental low speed handpiece
K181900 · EFB
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 511d
Cleared Dec 06, 2019
JJ Implant System
K190552 · DZE
Jj Implants
Dental · 276d
Cleared Dec 05, 2019
Southern Implants PEEK Abutments
K191250 · NHA
Southern Implants (Pty), Ltd.
Dental · 210d
Cleared Dec 05, 2019
Neodent Implant System - Temporary Abutments
K191191 · NHA
Jjgc Industria E Comercio DE...
Dental · 216d
Cleared Dec 05, 2019
MCI - CMF System
K182758 · JEY
Mci Medical Concept Innovation, Inc.
Dental · 433d
Cleared Dec 02, 2019
Zipbond
K191656 · KLE
Sdi Limited
Dental · 164d
Cleared Nov 27, 2019
3Shape Splint Design
K191911 · PNN
3Shape A/S
Dental · 133d
Cleared Nov 26, 2019
TRAUS Dental Handpieces
K182892 · EGS
Saeshin Precision Co., Ltd.
Dental · 407d
Cleared Nov 23, 2019
DEXIS CariVu 3-in-1 by KaVo
K182712 · NTK
Kaltenbach & Voigt GmbH
Dental · 422d
Cleared Nov 22, 2019
everX Flow
K192260 · EBF
GC America, Inc.
Dental · 93d
Cleared Nov 22, 2019
BruxZir GT (Gum Tissue) Color
K191903 · EIH
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Nov 22, 2019
Parkell Desensitizer Gel
K191103 · EJK
Parkell, Inc.
Dental · 211d
Cleared Nov 22, 2019
KLS Martin Individual Patient Solutions
K191028 · JEY
KLS-Martin L.P.
Dental · 218d