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
769–792 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 14, 2023
Yomi Robotic System
K231018 · PLV
Neocis, Inc.
Dental · 126d
Cleared Aug 11, 2023
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
K231696 · KLE
Prevest Denpro Limited
Dental · 60d
Cleared Aug 08, 2023
LW Implant System
K223924 · DZE
Ossvis Co., Ltd.
Dental · 221d
Cleared Aug 05, 2023
Stryker Resorbable Fixation System
K230733 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 142d
Cleared Aug 04, 2023
Dentis s-Clean Regular Abutment
K230126 · NHA
Dentis Co., Ltd.
Dental · 199d
Cleared Aug 04, 2023
CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
K223507 · EBZ
Good Doctors Co., Ltd.
Dental · 255d
Cleared Aug 01, 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
K230873 · NHA
Southern Implants (Pty), Ltd.
Dental · 124d
Cleared Jul 31, 2023
V-Print c&b temp
K231591 · POW
Voco GmbH
Dental · 60d
Cleared Jul 31, 2023
ZENEX Implant System_Narrow
K230630 · DZE
Izenimplant Co., Ltd.
Dental · 146d
Cleared Jul 28, 2023
Dia-Cem
K231552 · EMA
DiaDent Group International
Dental · 59d
Cleared Jul 28, 2023
Bright MTA Sealer Plus
K231480 · KIF
Genoss Co., Ltd.
Dental · 67d
Cleared Jul 25, 2023
Enamel Coating Resin
K230455 · EBC
Rizhao Huge Biomaterials Company, Ltd.
Dental · 154d
Cleared Jul 24, 2023
EsCom250
K231523 · EBF
Spident Co., Ltd.
Dental · 59d
Cleared Jul 24, 2023
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish...
K230333 · LBH
Kettenbach GmbH & Co. KG
Dental · 167d
Cleared Jul 18, 2023
Bone Chamber Implant
K223339 · DZE
Megagen Implant Co., Ltd.
Dental · 259d
Cleared Jul 18, 2023
TRUST
K221107 · PNP
Rgorithm Korea
Dental · 459d
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