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
145–168 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 18, 2025
Dental Cone
K253758 · OLR
Medizin Produkte Neustadt GmbH (Mpn)
Dental · 23d
Cleared Dec 18, 2025
Park Dental Nylon MAD
K252976 · LRK
Park Dental Research Corp.
Dental · 92d
Cleared Dec 18, 2025
SIMDA Abutments
K252320 · NHA
Simda Co., Ltd.
Dental · 146d
Cleared Dec 12, 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 101d
Cleared Dec 12, 2025
Pterygoid Indication for GM Helix Implants
K252090 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 163d
Cleared Dec 12, 2025
Jason membrane
K242817 · NPL
Botiss Biomaterials GmbH
Dental · 450d
Cleared Dec 09, 2025
GlasIonomer FX-LC
K252808 · EMA
Shofu Dental Corporation
Dental · 97d
Cleared Dec 09, 2025
Atlantis® Abutments in Titanium
K252343 · NHA
Dentsply Sirona
Dental · 134d
Cleared Dec 08, 2025
Glass Ceramic
K252789 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 97d
Cleared Dec 05, 2025
QuietLab Pro
K253868 · LRK
QuietLab, LLC
Dental · 2d
Cleared Dec 05, 2025
Any-Core
K252465 · EBF
Mediclus Co., Ltd.
Dental · 121d
Cleared Dec 05, 2025
els unibond
K252151 · KLE
Saremco Dental AG
Dental · 149d
Cleared Dec 05, 2025
Remvia NightGuard
K250743 · MQC
Remvia
Dental · 269d
Cleared Dec 05, 2025
Augmented Gingival Matrix
K250512 · NPL
Neo Modulus (Suzhou) Medical Sci-Tech...
Dental · 287d
Cleared Nov 27, 2025
Carriere® Motion Pro® Clear Bite Corrector
K252760 · DYW
Ortho Organizers, Inc.
Dental · 90d
Cleared Nov 26, 2025
CEREC Tessera Abutment System
K252248 · NHA
Dentsply Sirona
Dental · 131d
Not Cleared Nov 26, 2025
MuReva OM™
DEN240077 · SGQ
Mureva Phototherapy, Inc.
Dental · 338d
Cleared Nov 25, 2025
LuxCreo Flexible Partial Denture Resin
K253365 · EBI
LuxCreo, Inc.
Dental · 56d
Cleared Nov 25, 2025
Geistlich Mucograft® /Geistlich Mucograft® Seal
K252253 · NPL
Geistlich Pharma AG
Dental · 127d
Cleared Nov 25, 2025
Hushd Avera
K252161 · LRK
Good Sleep CO Pte , Ltd.
Dental · 138d
Cleared Nov 25, 2025
enCore Night Guard
K252004 · OBR
Encore Guards
Dental · 151d
Cleared Nov 21, 2025
TERA HARZ Hard Denture (THD-C-500)
K253681 · EBI
Graphy, Inc.
Dental
Cleared Nov 21, 2025
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants
K251205 · NHA
Dentsply Sirona
Dental · 217d
Cleared Nov 21, 2025
FluoroDose Varnish
K250714 · LBH
Centrix, Inc.
Dental · 256d