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
385–408 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 16, 2025
Pearl Clear Aligner
K242715 · NXC
Pearl Digital, Inc.
Dental · 128d
Cleared Jan 14, 2025
LOCATOR Angled Abutment
K243272 · NHA
Zest Anchors, LLC
Dental · 90d
Cleared Jan 13, 2025
MegaGen Dental Implant Abutment
K242030 · NHA
Megagen Implant Co., Ltd.
Dental · 186d
Cleared Jan 10, 2025
OverCEM SA Universal
K242366 · EMA
Overfibers S.R.L.
Dental · 154d
Cleared Jan 08, 2025
TRI-matrix® X-Force Implants
K242661 · DZE
Tri Dental Implants Int. AG
Dental · 126d
Cleared Jan 08, 2025
ReminGel
K241489 · LBH
Inter-Med, Inc.
Dental · 229d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Hiossen, Inc.
Dental · 271d
Cleared Jan 06, 2025
SD TL Implant System
K242753 · DZE
Arum Dentistry Co., Ltd.
Dental · 116d
Cleared Jan 03, 2025
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™...
K250015 · DYH
Ormco Corporation
Dental · 1d
Cleared Jan 03, 2025
Elemental Granulate
K241283 · OLR
Zinkh NV
Dental · 241d
Cleared Jan 03, 2025
NobelProcera Zirconia Implant Bridge
K240346 · NHA
Nobel Biocare AB
Dental · 333d
Cleared Jan 03, 2025
GBR System
K233419 · DZL
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 451d
Cleared Jan 02, 2025
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568 · LBH
GreenMark Biomedical, Inc.
Dental · 216d
Cleared Dec 27, 2024
BLUEDIAMOND IMPLANT
K241972 · DZE
Megagen Implant Co., Ltd.
Dental · 175d
Cleared Dec 27, 2024
Elastic Impression Material
K241924 · ELW
Beijing Okvd Biological Technology ,...
Dental · 179d
Cleared Dec 27, 2024
INNO SLA Mini Plus® Implant System
K241127 · DZE
Cowellmedi Co., Ltd.
Dental · 248d
Cleared Dec 26, 2024
Straumann CARES Visual and Nova Dental CAD
K233252 · PNP
Institut Straumann AG
Dental · 455d
Cleared Dec 23, 2024
Denture Base
K243103 · EBI
Riton 3D Technology Co., Ltd.
Dental · 84d
Cleared Dec 20, 2024
HPR Cordless Hygiene Handpiece
K243911 · EKX
Handpiece Headquarters
Dental · 1d
Cleared Dec 20, 2024
Fas Aligner System
K242929 · NXC
Xplora 3D Europe S.L
Dental · 87d
Cleared Dec 20, 2024
TopCEM-Try in Veneer Try-in Gel
K242572 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 113d
Cleared Dec 20, 2024
HF-Etchant Hydrofluoric Acid Etching Gel
K242530 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 116d
Cleared Dec 20, 2024
Alpha Dent Implants Dental Implants System
K240435 · DZE
Alpha Dent Implants GmbH
Dental · 310d
Cleared Dec 19, 2024
Quickdent Dental Implant System
K243094 · DZE
Quickdent Devices Private , Ltd.
Dental · 80d