FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,595 results
385–408 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 26, 2024
Straumann CARES Visual and Nova Dental CAD
K233252 · PNP
Institut Straumann AG
Dental · 455d
Cleared Dec 23, 2024
Denture Base
K243103 · EBI
Riton 3D Technology Co., Ltd.
Dental · 84d
Cleared Dec 20, 2024
HPR Cordless Hygiene Handpiece
K243911 · EKX
Handpiece Headquarters
Dental · 1d
Cleared Dec 20, 2024
Fas Aligner System
K242929 · NXC
Xplora 3D Europe S.L
Dental · 87d
Cleared Dec 20, 2024
TopCEM-Try in Veneer Try-in Gel
K242572 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 113d
Cleared Dec 20, 2024
HF-Etchant Hydrofluoric Acid Etching Gel
K242530 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 116d
Cleared Dec 20, 2024
Alpha Dent Implants Dental Implants System
K240435 · DZE
Alpha Dent Implants GmbH
Dental · 310d
Cleared Dec 19, 2024
Quickdent Dental Implant System
K243094 · DZE
Quickdent Devices Private , Ltd.
Dental · 80d
Cleared Dec 19, 2024
Cristaline Aligners Z FLX
K242892 · NXC
Cristaline Aligners GmbH
Dental · 87d
Cleared Dec 19, 2024
IPD Dental Implant Abutments
K242819 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 92d
Cleared Dec 18, 2024
3Delta UNlimited
K243720 · EBF
Deltamed GmbH
Dental · 15d
Cleared Dec 17, 2024
Lucitone Digital Print Denture™ System
K243336 · EBI
Dentsply Sirona, Inc.
Dental · 54d
Cleared Dec 17, 2024
Quantium
K242816 · EBF
Bisco, Inc.
Dental · 90d
Cleared Dec 17, 2024
ALLONUS Tech Prosthetics
K241616 · NHA
Allonus Tech Co., Ltd.
Dental · 195d
Cleared Dec 16, 2024
Dental Implants and Abutments
K243066 · DZE
Ditron Dental, Ltd.
Dental · 80d
Cleared Dec 12, 2024
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
K242934 · KIF
Longly Biotechnology (Wuhan) Co., Ltd.
Dental · 78d
Cleared Dec 12, 2024
visio.lign color, visio.lign shield
K240735 · EBD
Bredent GmbH & Co. KG
Dental · 269d
Cleared Dec 12, 2024
GENIOVA aligners
K233152 · NXC
Geniova Technologies Sociedad Limitada
Dental · 442d
Cleared Dec 11, 2024
TECHFIT DISRP® System
K242263 · DZJ
Techfit Digital Surgery, Inc.
Dental · 132d
Cleared Dec 10, 2024
Elos Accurate® Hybrid Base™
K242025 · NHA
Elos Medtech Pinol A/S
Dental · 152d
Cleared Dec 10, 2024
Straumann® PURE Ceramic Implants
K241391 · DZE
Institut Straumann AG
Dental · 209d
Cleared Dec 05, 2024
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
K242740 · EIH
Liaoning Rachcera Material Technology...
Dental · 85d
Cleared Dec 05, 2024
LW Pre-milled Abutment
K242703 · NHA
Ossvis Co., Ltd.
Dental · 87d
Cleared Dec 04, 2024
Neodent Implant System
K242686 · NHA
Jjgc Ind?stria E Com?rcia DE...
Dental · 89d