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
25–48 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 18, 2026
Curing Light (M-Cure 6)
K253131 · EBZ
Guangzhou Rebornendo Medical...
Dental · 266d
Cleared Jun 18, 2026
MegaGen Zygoma Dental Implant System
K251232 · DZE
Megagen Implant Co., Ltd.
Dental · 422d
Cleared Jun 18, 2026
Dental Implant System
K250806 · DZE
A.B. Dental Devices , Ltd.
Dental · 458d
Cleared Jun 17, 2026
INOSS System
K260006 · DZE
Inosys, Inc.
Dental · 166d
Cleared Jun 16, 2026
BOSS
K253723 · NPM
Medpark Co., Ltd.
Dental · 204d
Cleared Jun 15, 2026
Curajel™ Oral Gel
K260126 · OLR
USpharma, Ltd.
Dental · 151d
Cleared Jun 15, 2026
Neodent Scannable Healing Abutment
K253922 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 189d
Cleared Jun 12, 2026
Virtus
K261366 · LRK
Somnomed, Inc.
Dental · 46d
Cleared Jun 11, 2026
Snorbliss® Anti-Snoring Device
K261251 · LRK
Endeavor Commerce, LLC
Dental · 56d
Cleared Jun 11, 2026
Rosetta SM, Rosetta SP
K260859 · EIH
Hass Corp.
Dental · 87d
Cleared Jun 11, 2026
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
K254145 · NHA
Smart Denture Conversions, LLC
Dental · 171d
Cleared Jun 11, 2026
Fluoride Varnish (Type A,Type C)
K253052 · LBH
Nagy Oral Technology Qinhuangdao Co.,...
Dental · 262d
Cleared Jun 09, 2026
DESS Dental Smart Solutions
K260564 · NHA
Terrats Medical SL
Dental · 110d
Cleared Jun 03, 2026
BracePaste Prime Plus
K261840 · DYH
American Orthodontics
Dental · 1d
Cleared Jun 03, 2026
VSP System (Titanium Palatal Splint)
K261826 · DZJ
3D Systems, Inc.
Dental · 2d
Cleared Jun 03, 2026
SIC Abutments including CAD/CAM Solutions
K252904 · NHA
Sic Invent AG
Dental · 265d
Cleared Jun 02, 2026
DIAFIL
K261093 · EBF
DiaDent Group International
Dental · 61d
Cleared Jun 02, 2026
DB 4000 High Impact Denture Base
K260569 · EBI
Carbon, Inc.
Dental · 103d
Cleared May 29, 2026
LUNE PureHygiene
K260138 · GEX
Enamel Pure
Dental · 133d
Cleared May 21, 2026
MuCover (proposed name) Oral Wound Dressing
K253816 · OLR
MoleculeX Co., Ltd.
Dental · 174d
Cleared May 21, 2026
DCMhotbond zircon
K253191 · EIH
Dental Creativ Management GmbH
Dental · 237d
Cleared May 20, 2026
Elos Accurate® Denture Fixation System
K253774 · NHA
Elos Medtech Pinol A/S
Dental · 175d
Cleared May 19, 2026
DIAFIL Bulk FLOW (Economic Package)
K261071 · EBF
DiaDent Group International
Dental · 48d
Cleared May 19, 2026
OrthoEasy Pal
K260268 · OAT
Bernhard Förster GmbH (Bernhard...
Dental · 111d