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
1801–1824 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 29, 2019
3M RelyX Pediatric Resin Modified Glass Ionomer Cement
K191122 · EMA
3M Espe Dental Products
Dental · 30d
Cleared May 29, 2019
GuttaSil
K190510 · KIF
Meta Biomed Co., Ltd.
Dental · 89d
Cleared May 29, 2019
LuxaCrown, Shade A1, A2, A3, A3.5
K183337 · EBG
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 177d
Cleared May 24, 2019
Conical Plus Implant System
K181157 · DZE
Osseofuse International, Inc.
Dental · 388d
Cleared May 23, 2019
KATANA Zirconia Block
K190436 · EIH
Kuraray Noritake Dental, Inc.
Dental · 90d
Cleared May 22, 2019
Dental Ceramic
K182350 · EIH
Baot Biological Technology Co., Ltd.
Dental · 266d
Cleared May 21, 2019
ET IV SA Dental Implants
K183242 · DZE
Hiossen, Inc.
Dental · 181d
Cleared May 17, 2019
SD Abutment
K173570 · NHA
Surgident Co., Ltd.
Dental · 543d
Cleared May 09, 2019
Magic Clear Aligners
K190948 · NXC
Voodoo Manufacturing, Inc.
Dental · 28d
Cleared May 09, 2019
Encore System
K183310 · ORY
Siesta Medical, Inc.
Dental · 161d
Cleared May 08, 2019
SomnoDent Avant
K183443 · LRK
Somnomed, Inc.
Dental · 147d
Cleared May 07, 2019
OssBuilder System
K181854 · DZL
Osstem Implant Co., Ltd.
Dental · 300d
Cleared May 03, 2019
CLEARFIL MAJESTY IC
K182430 · EBF
Kuraray Noritake Dental, Inc.
Dental · 239d
Cleared May 03, 2019
armor LC
K182118 · EIE
Mavrik Dental Systems, Ltd.
Dental · 270d
Cleared Apr 29, 2019
VALO Grand Corded
K190627 · EBZ
Ultradent Products, Inc.
Dental · 48d
Cleared Apr 29, 2019
Compex HD
K182017 · QGO
Addent, Inc.
Dental · 276d
Cleared Apr 25, 2019
PANAVIA SA Cement Universal
K183537 · EMA
Kuraray Noritake Dental, Inc.
Dental · 127d
Cleared Apr 24, 2019
Halley resin
K190043 · EBI
Dentsply Sirona
Dental · 105d
Cleared Apr 22, 2019
LC GLOSSFILL XR
K182778 · EBF
S&C Polymer Silicon- Und Composite...
Dental · 203d
Cleared Apr 19, 2019
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
K181571 · PLC
Mark Abramson, D.D.S., Inc.
Dental · 309d
Cleared Apr 19, 2019
FUSION Plus Curing Light
K180065 · EBZ
Dentlight, Inc.
Dental · 465d
Cleared Apr 18, 2019
Orthodontic Appliance
K181747 · NXC
Shandong Huge Dental Material...
Dental · 290d
Cleared Apr 17, 2019
Straumann BLX Variobase Abutment
K190082 · NHA
Institut Straumann AG
Dental · 90d
Cleared Apr 16, 2019
General Cutting Contra Handpiece
K182999 · EGS
Nakanishi, Inc.
Dental · 168d