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
1825–1848 of 12,611
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