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
1321–1344 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 30, 2021
Metapaste Plus
K210904 · KIF
Meta Biomed Co., Ltd.
Dental · 96d
Cleared Jun 28, 2021
Diafil & Diafil Capsule
K210421 · EBF
DiaDent Group International
Dental · 137d
Cleared Jun 28, 2021
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K201353 · DZJ
Centermed, Inc.
Dental · 403d
Cleared Jun 24, 2021
Renamel Bulkfill
K211259 · EBF
Cosmedent, Inc.
Dental · 59d
Cleared Jun 24, 2021
Perfit FS Dental Zirconia Fully Sintered Block
K203590 · EIH
Vatech Acucera, Inc.
Dental · 198d
Cleared Jun 24, 2021
TMJ Relax
K202523 · OCO
Moonwalker Innovations, Inc.
Dental · 296d
Cleared Jun 23, 2021
S.I.N. Dental Implant System
K203725 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 184d
Cleared Jun 23, 2021
Straumann CARES M-Series CAD/CAM System
K203456 · NHA
Institut Straumann AG
Dental · 212d
Cleared Jun 22, 2021
AnyOne Onestage Implant System
K210161 · DZE
Megagen Implant Co., Ltd.
Dental · 152d
Cleared Jun 21, 2021
Straumann BLX Implant System
K210855 · DZE
Institut Straumann AG
Dental · 90d
Cleared Jun 21, 2021
Orthodontic Facemask
K202855 · DZB
Ita.O Italian Orthodontic System S.R.L.
Dental · 266d
Cleared Jun 21, 2021
coDiagnostiX
K193301 · DZJ
Dental Wings GmbH
Dental · 570d
Cleared Jun 18, 2021
Kontact Dental Implant System
K210220 · DZE
Biotech Dental, Sas
Dental · 142d
Cleared Jun 17, 2021
MIS Lance+ Conical Connection Dental Implant System
K210886 · DZE
Dentsply Sirona
Dental · 84d
Cleared Jun 16, 2021
Silent Nite Sleep Appliance with the Glidewell Hinge
K210694 · LRK
Prismatik Dentalcraft, Inc.
Dental · 100d
Cleared Jun 14, 2021
E-Temp
K211101 · EBG
Envisiontec GmbH
Dental · 62d
Cleared Jun 11, 2021
PANAVIA Veneer LC
K210504 · EMA
Kuraray Noritake Dental, Inc.
Dental · 109d
Cleared Jun 04, 2021
HIT Clear Aligner
K210613 · NXC
Cdb Corporation
Dental · 95d
Cleared Jun 04, 2021
Dentis s-Clean s-Line Mini
K210080 · DZE
Dentis Co., Ltd.
Dental · 143d
Cleared Jun 04, 2021
TruBase S
K201842 · NHA
Truabutment, Inc.
Dental · 333d
Cleared Jun 02, 2021
6MS Invisible Aligner
K210652 · NXC
Sms Opco, LLC
Dental · 90d
Cleared May 26, 2021
Implacil Implant System
K202832 · DZE
Implacil DE Bortoli Material...
Dental · 243d
Cleared May 25, 2021
E-Dent 1000
K210977 · EBF
Envisiontec GmbH
Dental · 54d
Cleared May 25, 2021
Tokuyama Universal Bond II
K203760 · KLE
Tokuyama Dental Corporation
Dental · 153d