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
745–768 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 22, 2023
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · LFD
Gurunanda, LLC
Dental · 117d
Cleared Aug 21, 2023
ACR Screw System
K222245 · OAT
Biomaterials Korea, Inc.
Dental · 391d
Cleared Aug 18, 2023
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro -...
K232498 · EBC
Ultradent Product, Inc.
Dental · 1d
Cleared Aug 18, 2023
Eco Abutment, Multiunit Abutment
K220253 · NHA
Dio Corporation
Dental · 564d
Cleared Aug 17, 2023
InterCollagen® Guide
K223912 · NPL
Sigmagraft, Inc.
Dental · 231d
Cleared Aug 16, 2023
Harvest Dental HD Gum Strip
K231389 · EBI
Harvest Dental Products, LLC
Dental · 96d
Cleared Aug 15, 2023
Implant-One System
K231455 · NHA
Implant Logistics, Inc.
Dental · 89d
Cleared Aug 14, 2023
DESS Dental Smart Solutions
K231434 · NHA
Terrats Medical SL
Dental · 89d
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