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
1–24 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 31, 2026
NanoCeram Resin
K262681 · EBI
3BFAB TEKNOLOJI A.S.
Dental · 1d
Cleared Jul 31, 2026
SnØreNegatØr
K261912 · LRK
DnB Innovations, LLC
Dental · 53d
Cleared Jul 31, 2026
Angled Screwdriver MED (M-SD090)
K253655 · DZI
W&H Dentalwerk B?rmoos GmbH
Dental · 253d
Cleared Jul 30, 2026
Obsidian® Press Over Zirconia
K262239 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Jul 29, 2026
Emanate Tray
K251908 · OLR
Emanate Biomedical
Dental · 404d
Cleared Jul 25, 2026
METICULY Patient-specific CMF solution
K253206 · JEY
Meticuly Co., Ltd.
Dental · 302d
Cleared Jul 21, 2026
One-Fil LC
K261728 · EJK
Mediclus Co., Ltd.
Dental · 56d
Cleared Jul 17, 2026
Dental Zirconia Blank & Coloring Liquid
K261046 · EIH
Hunan Qinghao Puzhong Technology Co.,...
Dental · 108d
Cleared Jul 09, 2026
DIA-CEM
K261166 · EMA
DiaDent Group International
Dental · 91d
Cleared Jul 08, 2026
Denture Base Resin V2
K262300 · EBI
Formlabs Ohio, Inc.
Dental · 1d
Cleared Jul 06, 2026
Cytrans™ Elashield
K253317 · LYC
GC America, Inc.
Dental · 279d
Cleared Jul 02, 2026
iTero Lumina™ Pro
K261847 · NTK
Align Technology , Ltd.
Dental · 29d
Cleared Jul 02, 2026
OrthoFit
K261129 · DYH
Spident Co., Ltd.
Dental · 87d
Cleared Jul 02, 2026
FACE4D Aligner
K260527 · NXC
Avinent Implant System S.L.U.
Dental · 135d
Cleared Jul 01, 2026
Transcend Bulk Fill Flowable Composite
K262228 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jul 01, 2026
Tetric plus Fill
K261485 · EBF
Ivoclar Vivadent, Inc.
Dental · 57d
Cleared Jul 01, 2026
DENTCA Tru Flexible
K261474 · EBI
Dentca, Inc.
Dental · 58d
Cleared Jul 01, 2026
Neodent Implant System - NeoConvert Fit
K261147 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 85d
Cleared Jun 27, 2026
MIST IC
K261122 · NHA
Imagine Milling Technologies, LLC
Dental · 85d
Cleared Jun 26, 2026
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
K260061 · NHA
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Jun 25, 2026
G-Series Grind Guard
K260790 · OBR
ASESSO HEALTH, Inc.
Dental · 106d
Cleared Jun 25, 2026
UNIQA® Dental Implants System
K251188 · DZE
Uniqa Dental, Ltd.
Dental · 434d
Cleared Jun 18, 2026
SRGC-06
K261246 · EBF
GC America, Inc.
Dental · 63d
Cleared Jun 18, 2026
Implantmed Plus II & Piezomed Plus II Module
K253776 · DZI
W&H Dentalwerk Buermoos GmbH
Dental · 204d