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
1561–1584 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 06, 2020
RC-Prime Root Canal Preparation Cream
K200330 · KJJ
Pac-Dent, Inc.
Dental · 147d
Cleared Jul 06, 2020
MIS Ti-base Abutment
K191152 · NHA
Dentsply Sirona
Dental · 432d
Cleared Jul 02, 2020
GC Fuji Triage EP
K193484 · EMA
GC America, Inc.
Dental · 198d
Cleared Jul 02, 2020
IC-WHCD100 (Inspire)
K183471 · NBL
Good Doctors Co., Ltd.
Dental · 566d
Cleared Jun 30, 2020
Surgical Drills
K200265 · DZI
Implant Direct Sybron Manufacturing, LLC
Dental · 148d
Cleared Jun 30, 2020
Dental Electrical Motor iRoot Pro
K191276 · EKX
Changzhou Bomedent Medical Technology...
Dental · 414d
Cleared Jun 26, 2020
MSDI Dental Implants System
K191443 · DZE
Medical Systems and Devices...
Dental · 393d
Cleared Jun 26, 2020
JDentalCare Implant System JDIcon
K182081 · DZE
Jdentalcare Srl
Dental · 694d
Cleared Jun 25, 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · LBH
Largent Health, LLC
Dental · 108d
Cleared Jun 25, 2020
DIA-ROOT BIO Sealer
K200175 · KIF
DiaDent Group International
Dental · 154d
Cleared Jun 25, 2020
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants
K192221 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 315d
Cleared Jun 23, 2020
VarseoSmile Crown plus
K201668 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 4d
Cleared Jun 23, 2020
ULab Systems uDesign Software
K200772 · PNN
Ulab Systems, Inc.
Dental · 90d
Cleared Jun 19, 2020
TruAbutment DS
K191913 · NHA
Truabutment, Inc.
Dental · 338d
Cleared Jun 19, 2020
Fit & Brilliant Dental Implant System
K190637 · DZE
F&B Technology Co., Ltd.
Dental · 465d
Cleared Jun 18, 2020
NUVO IF Implant System
K193234 · DZE
Jjgc Industria E Comercio DE...
Dental · 206d
Cleared Jun 18, 2020
BV Dental Implant System
K192274 · DZE
Bio Concept Co., Ltd.
Dental · 301d
Cleared Jun 17, 2020
Yxoss CBR®
K192747 · JEY
Reoss GmbH
Dental · 261d
Cleared Jun 10, 2020
BruxZir Steel
K200131 · EIH
Prismatik Dentalcraft, Inc.
Dental · 141d
Cleared Jun 09, 2020
IBS Implant System II
K200753 · NHA
Innobiosurg Co., Ltd.
Dental · 78d
Cleared Jun 09, 2020
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour...
K192033 · DZI
Bennett Jacoby, Dds, Ms, Inc.
Dental · 315d
Cleared Jun 09, 2020
ImmersiveView Surgical Plan (IVSP®)
K181813 · DZJ
Immersivetouch
Dental · 704d
Cleared Jun 05, 2020
NemoCast
K193003 · PNN
Software Nemotec S.L.
Dental · 221d
Cleared Jun 01, 2020
SleepRight ProRx Custom Dental Guard
K193577 · OBR
Splintek, Inc.
Dental · 161d