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
457–480 of 12,611
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