FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,611 results
1273–1296 of 12,611
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