Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Dental ×
12,659 results
433–456 of 12,659
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