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
1345–1368 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 21, 2021
Impla-NX (Model: ISE-270M)
K201192 · EBW
Micro-Nx Co., Ltd.
Dental · 382d
Cleared May 19, 2021
Ohlendorf Clear Aligner
K210540 · NXC
Ohlendorf Appliance Laboratory
Dental · 84d
Cleared May 19, 2021
TECHFIT Patient-Specific Maxillofacial System
K203282 · JEY
Industrias Medicas Sampedro S.A.S
Dental · 194d
Cleared May 14, 2021
BoneTrust Mini Implant System
K200573 · DZE
Medical Instinct Deutschland GmbH
Dental · 435d
Cleared May 13, 2021
Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron...
K200555 · EMA
Prevest Denpro Limited
Dental · 436d
Cleared May 10, 2021
Endo Motor
K203320 · EKX
Guilin Woodpecker Medical Instrument...
Dental · 179d
Cleared May 05, 2021
GR-14 Resin System
K210298 · EBI
Pro3dure Medical GmbH
Dental · 91d
Cleared May 05, 2021
D function
K203525 · NUW
Ito Co., Ltd.
Dental · 155d
Cleared Apr 27, 2021
AccelX Abutments
K203240 · NHA
Integrated Dental Systems, LLC
Dental · 175d
Cleared Apr 26, 2021
Illusion Aligners
K211010 · NXC
Laxmi Dental Exports Pvt, Ltd.
Dental · 21d
Cleared Apr 26, 2021
VSP System
K210347 · DZJ
3D Systems
Dental · 77d
Cleared Apr 23, 2021
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
K211190 · NXC
3M Company, Unitek Orthodontic Products
Dental · 2d
Cleared Apr 22, 2021
IDCAM Dental Implants
K200329 · DZE
Implants Diffusion International
Dental · 437d
Cleared Apr 20, 2021
Panthera Occlusal Appliance
K203596 · MQC
Panthera Dental, Inc.
Dental · 132d
Cleared Apr 19, 2021
Dentis s-Clean s-Line
K210134 · DZE
Dentis Co., Ltd.
Dental · 90d
Cleared Apr 19, 2021
VPS Impression Material
K203824 · ELW
Hygedent, Inc.
Dental · 111d
Cleared Apr 15, 2021
Locator Overdenture Implant System
K203701 · DZE
Ivory Super Holdco Inc. / Zest...
Dental · 118d
Cleared Apr 14, 2021
Metapex Plus
K202617 · KIF
Meta Biomed Co., Ltd.
Dental · 217d
Cleared Apr 13, 2021
EndoPilot2
K202906 · ELC
Schlumbohm GmbH & Co. KG
Dental · 196d
Cleared Apr 09, 2021
KeyPrint KeySplint Hard
K203000 · MQC
Mycone Dental Supply Co. Inc. (Dba...
Dental · 190d
Cleared Apr 09, 2021
PuRE PMMA Disc
K201563 · EBG
Quest Dental USA Corp.
Dental · 303d
Cleared CT Apr 05, 2021
Oral-B Dry Mouth Oral Rinse
K203567 · LFD
The Procter & Gamble Company
Dental · 119d
Cleared Apr 05, 2021
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
K203499 · EIH
Vatech Acucera, Inc.
Dental · 129d
Cleared Apr 02, 2021
CreoDent Solidex Customized Abutment
K202909 · NHA
Creodent Prosthetics, Ltd.
Dental · 185d