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
1657–1680 of 12,611
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