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
73–96 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
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