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
1–24 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 30, 2026
Shining3D Clear Aligner System
K263860 · NXC
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Oct 30, 2026
Zirconia Collective 4Y Dental Zirconia Blank
K262685 · EIH
Zirconia Collective, Inc.
Dental · 91d
Cleared Oct 29, 2026
Zirconia Dental Ceramics and Staining Solution
K262756 · EIH
Fanen New Materials Technology...
Dental · 87d
Cleared Oct 29, 2026
OSSIX Plus
K262415 · NPL
Datum Dental, Ltd.
Dental · 106d
Cleared Oct 29, 2026
EndoColibri
K260356 · NYL
Koehrer Medical Engineering GmbH
Dental · 268d
Cleared Oct 27, 2026
AquaVance Clear Fluoride Treatment
K262775 · LBH
The Belport Company Inc., DBA Gingi-Pak
Dental · 83d
Cleared Oct 26, 2026
Mouth guard
K262280 · OBR
Dongguan Yiyao Science & Technology...
Dental · 112d
Cleared Oct 23, 2026
LuxDesign
K260421 · PNN
LuxCreo, Inc.
Dental · 256d
Cleared Oct 23, 2026
Mobile Dental Solution (Model: DS50, DS70, DS90)
K260275 · EIA
Guangdong Jinme Medical Technology...
Dental · 267d
Cleared Oct 22, 2026
MultiNeO Dental Implant System
K261295 · DZE
Alpha-Bio Tec , Ltd.
Dental · 185d
Cleared Oct 21, 2026
INNI-CERA (BCM-W500, BCM-W1000)
K262980 · EIH
DentMedi Co., Ltd.
Dental · 55d
Cleared Oct 20, 2026
PDR Airway Device
K262937 · LRK
Park Dental Research Corp.
Dental · 60d
Cleared Oct 20, 2026
Daybreak Impression Material
K262421 · SHI
Sleepcare, LLC
Dental · 96d
Cleared Oct 16, 2026
Amber Arte
K262523 · EIH
Hass Corp.
Dental · 86d
Cleared Oct 16, 2026
BCS Bioceramic Sealer
K262478 · KIF
BCS Device Pte., Ltd.
Dental · 88d
Cleared Oct 13, 2026
OrthoFit Aligner (OrthoFit Aligner A2)
K262433 · DYH
Spident Co., Ltd.
Dental · 89d
Cleared Oct 13, 2026
Yomi S Robotic System
K261321 · QRY
Neocis, Inc.
Dental · 174d
Cleared Oct 09, 2026
CMF Titanium Splints
K260913 · DZJ
Materialise NV
Dental · 204d
Cleared Oct 09, 2026
Wishbone HAE
K260096 · NPM
Wishbone SA
Dental · 269d
Cleared Oct 08, 2026
One Coat Bond
K263680 · KLE
Dent4you AG
Dental · 1d
Cleared Oct 07, 2026
Dr.AlignNavi
K262378 · PNN
InnoDtech, Inc.
Dental · 86d
Cleared Oct 06, 2026
Forza
K260136 · LRK
True Function Laboratory, Inc.
Dental · 263d
Cleared Oct 01, 2026
Firstar Dental Handpieces
K260029 · EFB
FDC Technology Industry Co.
Dental · 269d
Cleared Oct 01, 2026
Firstar Dental Electric Motor
K260027 · EBW
FDC Technology Industry Co.
Dental · 269d