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
2401–2424 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 26, 2016
GPS Angled Abutment
K153509 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 263d
Cleared Aug 26, 2016
CompleClear Plastic Orthodontic Bracket and Wire Appliance
K150830 · DYW
Oracrew
Dental · 515d
Cleared Aug 23, 2016
KATANA AVENCIA Block
K153476 · EBF
Kuraray Noritake Dental, Inc.
Dental · 265d
Cleared Aug 22, 2016
Premium Plus C01/C02 LED Curing Light
K153514 · EBZ
Premium Plus International Limited
Dental · 259d
Cleared Aug 15, 2016
Oral Surgery System and Accessories
K152125 · DZI
Bonart Co., Ltd.
Dental · 381d
Cleared Aug 12, 2016
CELTRA Press
K161269 · EIH
Dentsply Sirona
Dental · 99d
Cleared Aug 12, 2016
EMS-200
K153285 · EKX
Meta Systems Co., Ltd.
Dental · 274d
Cleared Aug 11, 2016
OT EQUATOR
K160382 · NHA
Rhein 83 Srl
Dental · 183d
Cleared Aug 10, 2016
TAP 3, TAP 1
K160239 · PLC
Airway Management, Inc.
Dental · 191d
Cleared Aug 09, 2016
SnoreRx
K153200 · LRK
Apnea Sciences Corporation
Dental · 279d
Cleared Aug 05, 2016
Burn-out Cylinder and Angled Screw Abutments
K160483 · NHA
Dentium Co., Ltd.
Dental · 165d
Cleared Aug 05, 2016
ArgenIS Titanium Abutments
K160248 · NHA
Argen Corporation
Dental · 186d
Cleared Aug 05, 2016
Image Fast Set, Image Regular Set
K160097 · ELW
Sybron Dental Specialties
Dental · 199d
Cleared Aug 04, 2016
OSSIX PLUS
K160281 · NPL
Datum Dental, Ltd.
Dental · 184d
Cleared Aug 04, 2016
OSSIX VOLUMAX
K153549 · NPL
Datum Dental, Ltd.
Dental · 237d
Cleared Aug 04, 2016
CAPO BULK FILL
K152471 · EBF
Schuetz Dental GmbH
Dental · 339d
Cleared Aug 03, 2016
IonoStar Plus
K160774 · EMA
Voco GmbH
Dental · 135d
Cleared Aug 03, 2016
IMMEDIATELOAD Dental Implant System
K151757 · DZE
Immediateload S.A.
Dental · 401d
Cleared Aug 03, 2016
A-Oss
K151542 · NPM
Hiossen, Inc.
Dental · 422d
Cleared Jul 29, 2016
TheraCem
K161256 · EMA
Bisco, Inc.
Dental · 86d
Cleared Jul 29, 2016
The Luco Hybrid OSA Appliance
K160477 · OCO
Luco Hybrid Osa Appliance, Inc.
Dental · 161d
Cleared Jul 29, 2016
Clip Flow
K153493 · EBF
Voco GmbH
Dental · 238d
Cleared Jul 27, 2016
BEAUTIFIL II LS
K160596 · EBF
Shofu Dental Corporation
Dental · 147d
Cleared Jul 27, 2016
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K160367 · EIH
Nissin-Metec China Co., Ltd.
Dental · 169d