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
505–528 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 15, 2024
DenMat Bulk Fill Composite
K242097 · EBF
Den-Mat Holdings, LLC
Dental · 89d
Cleared Oct 15, 2024
Denture Base Resin (PN-Denture (Red, White))
K241673 · EBF
Shenzhen Piocreat 3D Technology Co.,...
Dental · 126d
Cleared Oct 11, 2024
Progressive Orthodontics App
K241153 · PNN
Progressive Aligners, Inc.
Dental · 168d
Cleared Oct 11, 2024
Spark™ Clear Aligner System
K240501 · NXC
Ormco Corporation
Dental · 233d
Cleared Oct 11, 2024
JDZygoma dental implants
K240143 · DZE
Jdentalcare Srl
Dental · 267d
Cleared Oct 10, 2024
Dental porcelain powder
K242400 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 58d
Cleared Oct 10, 2024
BTI Interna 3.0 Dental Implant System UnicCa®
K240262 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 253d
Cleared Oct 09, 2024
TruAbutment DS
K241485 · NHA
Truabutment, Inc.
Dental · 138d
Cleared Oct 08, 2024
Jet Flow Bulk
K242014 · EBF
Meta Biomed Co., Ltd.
Dental · 90d
Cleared Oct 03, 2024
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
K241977 · KIF
Longly Biotechnology (Wuhan) Co., Ltd.
Dental · 90d
Cleared Oct 03, 2024
Additive Manufacturing Zirconia Customized Restoration
K240586 · ELL
Hangzhou Thales Medtech Co., Ltd.
Dental · 216d
Cleared Oct 03, 2024
Rest Assure System
K233497 · PLC
Somnomed, Inc.
Dental · 338d
Cleared Oct 02, 2024
Ceramic Etchant (HF-5 and HF-9)
K240153 · KLE
Liaoning Upcera Co., Ltd.
Dental · 257d
Cleared Oct 01, 2024
Crown HT
K242277 · EBF
Sprintray, Inc.
Dental · 61d
Cleared Sep 30, 2024
LUXEN 5G
K241151 · EIH
Dentalmax Co., Ltd.
Dental · 158d
Cleared Sep 26, 2024
Any-Com
K241147 · EBF
Mediclus Co., Ltd.
Dental · 154d
Cleared Sep 20, 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880 · EFB
Nakanishi, Inc.
Dental · 84d
Cleared Sep 19, 2024
Star E900 Handpiece Series
K240183 · EGS
Dentalez, Inc., Stardental Division
Dental · 240d
Cleared Sep 18, 2024
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K234142 · NHA
Megagen Implant Co., Ltd.
Dental · 264d
Cleared Sep 18, 2024
Copra Supreme
K233064 · EIH
Whitepeaks Dental Solutions GmbH
Dental · 358d
Cleared Sep 17, 2024
Signum composite flow
K240660 · EBF
Kulzer, LLC
Dental · 193d
Cleared Sep 17, 2024
KLS Martin Drill-Free MMF Screw
K233721 · DZL
KLS-Martin L.P.
Dental · 301d
Cleared Sep 16, 2024
DNA Appliance
K234089 · LRK
Vivos Therapeutics
Dental · 269d
Cleared Sep 13, 2024
Elos Accurate® Hybrid Base™
K241722 · NHA
Elos Medtech Pinol A/S
Dental · 91d