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
1873–1896 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 16, 2019
MIST IC
K182246 · NHA
Imagine Milling Technologies, LLC
Dental · 239d
Cleared Apr 12, 2019
ArgenZ HT+
K190079 · EIH
The Argen Corporation
Dental · 86d
Cleared Apr 11, 2019
VisCalor bulk
K190453 · EBF
Voco GmbH
Dental · 45d
Cleared Apr 11, 2019
PureSleep (OTC use)
K190058 · LRK
Sleep Science Partners, Inc.
Dental · 90d
Cleared Apr 11, 2019
Brux Night Guard
K181361 · MQC
Brux Night Guard
Dental · 323d
Cleared Apr 10, 2019
PROPHYflex 4
K181110 · EFB
Kaltenbach & Voigt GmbH
Dental · 348d
Cleared Apr 08, 2019
Straumann BLX Line Extension - New Abutments
K190040 · NHA
Institut Straumann AG
Dental · 90d
Cleared Apr 04, 2019
Prettau, ICE, Z-White zirconia blanks
K183304 · EIH
Zirkonzahn Srl
Dental · 127d
Cleared Apr 01, 2019
Le'Pen
K181597 · EBZ
Kmihh, Ltd.
Dental · 287d
Cleared Mar 29, 2019
Delphos Implants Rigid Fixation System
K182609 · JEY
Delphos Implants - Ind.Com....
Dental · 189d
Cleared Mar 29, 2019
Reflect Implant System
K180924 · DZE
Ids - Integrated Dental Systems
Dental · 354d
Cleared Mar 26, 2019
Dental Pain Eraser
K182947 · LWM
Synapse Dental, LLC
Dental · 154d
Cleared Mar 26, 2019
Electric Handpiece Motor
K181858 · EBW
W&H Dentalwerk Buermoos GmbH
Dental · 257d
Cleared Mar 20, 2019
Jensen Shade Effect Liquids
K183408 · EIH
Jensen Industries, Inc.
Dental · 100d
Cleared Mar 18, 2019
Preat Abutments
K183518 · NHA
Preat Corporation
Dental · 90d
Cleared Mar 16, 2019
Sonendo GentleWave System
K190359 · ELC
Sonendo, Inc.
Dental · 29d
Cleared Mar 14, 2019
Tetric PowerFill
K183380 · EBF
Ivoclar Vivadent, AG
Dental · 98d
Cleared Mar 13, 2019
DePuy Synthes Maxillofacial Portfolio - MR Conditional
K183113 · MQN
Synthes USA Products, LLC
Dental · 124d
Cleared Mar 11, 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789 · DZJ
KLS-Martin L.P.
Dental · 161d
Cleared Mar 11, 2019
BoneTrust Implant System
K182313 · DZE
Medical Instinct Deutschland GmbH
Dental · 196d
Cleared Mar 08, 2019
ZAPnea Oral Appliance
K173064 · LRK
B. Fareid, Dds, PC
Dental · 525d
Cleared Mar 01, 2019
BrackFix
K183147 · DYH
Voco GmbH
Dental · 108d
Cleared Mar 01, 2019
DTX Studio design
K181932 · PNP
Nobel Biocare AB
Dental · 225d
Cleared Feb 27, 2019
AeroPro Cordless Prophy System
K180682 · EKX
Premier Dental Company Products
Dental · 349d