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
1753–1776 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 02, 2019
Allcem, Allcem Core
K183465 · EMA
Dentscare Ltda
Dental · 323d
Cleared Nov 01, 2019
ZMAXX Dental Zirconia Blanks
K191631 · EIH
Zmaxx Bioceramics, LLC
Dental · 135d
Cleared Nov 01, 2019
NextDent Denture 3D+
K191497 · EBI
Vertex-Dental B.V.
Dental · 149d
Cleared Nov 01, 2019
VPro5
K183018 · OYH
Propel Orthodontics, LLC
Dental · 366d
Cleared Oct 31, 2019
ADH19
K192961 · KLE
3M Deutschland GmbH
Dental · 9d
Cleared Oct 29, 2019
W Zirconia Implants
K192053 · DZE
Tav Medical , Ltd.
Dental · 90d
Cleared Oct 29, 2019
MATRx Plus
K191925 · MNR
Zephyr Sleep Technologies
Dental · 103d
Cleared Oct 29, 2019
BRILLIANT COMPONEER
K191385 · EBF
Coltene/Whaledent AG
Dental · 159d
Cleared Oct 28, 2019
Straumann PUREloc abutments
K192029 · NHA
Institut Straumann AG
Dental · 90d
Cleared Oct 20, 2019
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
K190124 · ELC
E.M.S Electro Medical Systems S.A
Dental · 268d
Cleared Oct 11, 2019
Razor, Everest, U&C Liquid
K191902 · EIH
U&C International Co., Ltd.
Dental · 87d
Cleared Oct 11, 2019
Nexus Universal Self-Cure
K191548 · EMA
Kerr Corporation
Dental · 121d
Cleared Oct 10, 2019
Legacy SMARTBase Abutments
K191458 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 132d
Cleared Oct 09, 2019
Visalys Restorative Primer
K191523 · KLE
Kettenbach GmbH & Co. KG
Dental · 121d
Cleared Oct 09, 2019
AnyRidge Octa 1 Implant System
K182448 · DZE
Megagen Implant Co., Ltd.
Dental · 397d
Cleared Oct 08, 2019
Barrier Sleeves
K191448 · PEM
Ivoclar Vivadent, AG
Dental · 130d
Cleared Oct 08, 2019
KATANA Cleaner, KATANA Cleaner (Trial)
K191133 · PME
Kuraray Noritake Dental, Inc.
Dental · 162d
Cleared Oct 08, 2019
Advanced Intermezzo Implant System
K191127 · DZE
Megagen Implant Co., Ltd.
Dental · 162d
Cleared Oct 04, 2019
Ceramill A-Temp
K191843 · EBG
Amann Girrbach AG
Dental · 87d
Cleared Oct 04, 2019
Tokuyama Rebase III
K190940 · EBI
Tokuyama Dental Corporation
Dental · 177d
Cleared Oct 03, 2019
Propex IQ Apex Locator
K191806 · LQY
Dentsply Sirona
Dental · 90d
Cleared Oct 03, 2019
Vintage Art Universal
K191794 · EIH
Shofu Dental Corporation
Dental · 92d
Cleared Oct 03, 2019
ALFA GATE Dental Implants System
K182143 · DZE
Alfa Gate Mazen, Ltd.
Dental · 422d
Cleared Oct 02, 2019
Neocis Planning Software Application (NPSA) for 3rd Party PCs
K191363 · PLV
Neocis, Inc.
Dental · 133d