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
793–816 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 13, 2023
Clear Aligner
K223517 · NXC
Wuxi EA Medical Instruments...
Dental · 202d
Cleared Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
K231347 · EIH
Prismatik Dentalcraft, Inc.
Dental · 31d
Cleared Jun 09, 2023
OrthoPulse 2.0E (OPi2E-100)
K230905 · PLH
Biolux Technology GmbH
Dental · 70d
Cleared Jun 08, 2023
SNUCONE Tissue Level Implant System
K222792 · DZE
Snucone Co., Ltd.
Dental · 265d
Cleared Jun 06, 2023
A-Line Advanced
K231635 · NJM
Biocetec Co., Ltd.
Dental · 1d
Cleared Jun 05, 2023
DynaFlex Clear Brackets & Buttons
K230225 · NJM
Dyna Flex
Dental · 129d
Cleared Jun 04, 2023
Stella
K221752 · DZE
Shinhung Mst Co., Ltd.
Dental · 353d
Cleared Jun 02, 2023
Titanium Turbine
K230888 · EFB
Nakanishi, Inc.
Dental · 63d
Cleared Jun 02, 2023
Harvest Conceal ZR Block Out
K222961 · EIH
Harvest Dental Products, LLC
Dental · 248d
Cleared May 31, 2023
iRoot SP Plus
K231259 · KIF
Innovative Bioceramix, Inc.
Dental · 30d
Cleared May 25, 2023
Soreal Press, Soreal CAD
K230259 · EIH
Shenzhen Up3D Technology Co., Ltd.
Dental · 114d
Cleared May 25, 2023
Dentis s-Clean SQ-SL Narrow Implant System
K230246 · NHA
Dentis Co., Ltd.
Dental · 115d
Cleared May 25, 2023
Genesis ACTIVE Implant System
K223814 · DZE
Keystone Dental, Inc.
Dental · 156d
Cleared May 25, 2023
Dental Desensitizer
K222891 · LBH
Guangzhou Beogene Biotech Co., Ltd.
Dental · 244d
Cleared May 24, 2023
s-Clean Link Abutment Narrow
K230523 · NHA
Dentis Co., Ltd.
Dental · 86d
Cleared May 24, 2023
General Cutting Straight
K230106 · EGS
Nakanishi, Inc.
Dental · 131d
Cleared May 24, 2023
SIMDA Abutment
K223663 · NHA
Simda Co., Ltd.
Dental · 168d
Cleared May 22, 2023
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K231464 · NXC
3M Company, Unitek Orthodontic Products
Dental · 3d
Cleared May 22, 2023
Hi-Bond Universal
K230465 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 18, 2023
Endo Motor
K220829 · EKX
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 422d
Cleared May 16, 2023
BruxZir™ Incisal Coloring Liquid
K230262 · EIH
Prismatik Dentalcraft, Inc.
Dental · 105d
Cleared May 16, 2023
BlueCheck™ Caries Detection & Monitoring
K222560 · LFC
Incisive Technologies Pty, Ltd.
Dental · 265d
Cleared May 15, 2023
Combi Touch
K231391 · ELC
Mectron S.P.A.
Dental · 3d
Cleared May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
K222836 · NHA
Institut Straumann AG
Dental · 237d