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
769–792 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 14, 2023
OnX Tough
K230445 · EBI
Sprintray, Inc.
Dental · 143d
Cleared Jul 14, 2023
Proxeo ULTRA (PB-510, PB-520 and PB-530)
K223173 · ELC
W&H Dentalwerk Buermoss GmbH
Dental · 276d
Cleared Jul 14, 2023
Neodent Implant System - Zirconia Implant System
K222026 · NHA
Jjgc Industria E Comercio DE...
Dental · 368d
Cleared Jul 14, 2023
Bonafix TiBase
K221673 · NHA
Zentek Medical, LLC
Dental · 400d
Cleared Jul 13, 2023
Admira Fusion 5
K230877 · EBF
Voco GmbH
Dental · 105d
Cleared Jul 12, 2023
RADx Intraoral Appliance for Snoring and Sleep Apnea
K230532 · LQZ
Achaemenid, LLC
Dental · 135d
Cleared Jul 11, 2023
Dentis i-Clean System
K230307 · NHA
Dentis Co., Ltd.
Dental · 158d
Cleared Jul 10, 2023
Endofill
K231387 · KIF
Lumendo AG
Dental · 59d
Cleared Jul 07, 2023
Cleo
K232011 · NJM
American Orthodontics
Dental · 1d
Cleared Jul 07, 2023
IH Implant System
K222707 · DZE
Sewonmedix, Inc.
Dental · 303d
Cleared Jul 03, 2023
Dental Lithium Disilicate Glass-Ceramic
K230487 · EIH
Fuzhou Rick Brown Biomaterials Co., Ltd.
Dental · 130d
Cleared Jul 01, 2023
NB Implant System
K230725 · DZE
Arum Dentistry Co., Ltd.
Dental · 107d
Cleared Jun 30, 2023
Easy On Universal Glaze & Stain
K231264 · EIH
Doctus Global
Dental · 59d
Cleared Jun 26, 2023
Z7 Zirconia Implant System
K221488 · DZE
Z7, LLC
Dental · 399d
Cleared Jun 24, 2023
BR SLA Type Implant System
K222142 · DZE
Biotem Co., Ltd.
Dental · 339d
Cleared Jun 23, 2023
DD medical polymers (PMMA)
K230410 · EBI
Dental Direkt GmbH
Dental · 128d
Cleared Jun 23, 2023
TECHFIT DISRP® System
K230276 · DZJ
Techfit Digital Surgery
Dental · 142d
Cleared Jun 23, 2023
Neodent Implant System - Helix Short Implant System
K223638 · DZE
Jjgc Industria E Comercio DE...
Dental · 200d
Cleared Jun 23, 2023
Black Diamond
K222323 · PHR
Elevate Oral Care, LLC
Dental · 325d
Cleared Jun 22, 2023
Straumann SLActive labeling changes
K223083 · DZE
Institut Straumann AG
Dental · 265d
Cleared Jun 20, 2023
SMARTbase Abutment System
K223535 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 209d
Cleared Jun 20, 2023
Perfit CL
K223029 · EIH
Vatech Mcis Co., Ltd.
Dental · 264d
Cleared Jun 14, 2023
IR SLA Type Implant System
K222144 · DZE
Biotem Co., Ltd.
Dental · 329d
Cleared Jun 13, 2023
iOrtho
K223518 · PNN
Shanghai EA Medical Instruments Co.,...
Dental · 202d