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
865–888 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared May 12, 2023
PMMA BLOCK
K223706 · EBG
Huliang(Shanghai) Bio-Tech Co., Ltd.
Dental · 151d
Cleared May 12, 2023
Harvest Printable Resin
K222489 · EBI
Harvest Dental Products, LLC
Dental · 268d
Cleared May 12, 2023
IU Implant System Abutment
K221969 · NHA
Warantec Co., Ltd.
Dental · 311d
Cleared May 11, 2023
OpenTex
K222549 · NPK
Purgo Biologics, Inc.
Dental · 261d
Cleared May 10, 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338 · LBH
3M Espe Dental Products
Dental · 2d
Cleared May 10, 2023
Emerald Herbst
K223624 · LRK
Island Dental Lab, Inc Dba Emerald...
Dental · 156d
Cleared May 05, 2023
ELEC Master, ELEC Master Dual
K202963 · EIA
Mgnewton , Ltd.
Dental · 947d
Cleared May 04, 2023
Ceramic Brackets Orthometric
K222847 · NJM
Orthometric - Industria E Comercio DE...
Dental · 225d