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
1201–1224 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 13, 2021
UltraCal XS
K211905 · KIF
Ultradent Products, Inc.
Dental · 114d
Cleared Oct 09, 2021
Straumann CARES P-Series CAD/CAM System
K203750 · NHA
Institut Straumann AG
Dental · 290d
Cleared Oct 08, 2021
Clear Aligner
K203688 · NXC
Wuxi EA Medical Instruments...
Dental · 295d
Cleared Oct 08, 2021
The Micro Screw System, Micro Screw System Basic
K201210 · DZL
Hager& Meisinger GmbH
Dental · 521d
Cleared Oct 06, 2021
TrusFIL Universal Composite Restorative
K202063 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 436d
Cleared Oct 04, 2021
INNI-CERA
K211308 · EIH
Aon Co., Ltd.
Dental · 158d
Cleared Oct 01, 2021
BRIUS Planner Software
K212828 · PNN
Brius Technologies, Inc.
Dental · 28d
Cleared Sep 30, 2021
Implanova
K210523 · DZE
Dental Evolutions, Inc.
Dental · 219d
Cleared Sep 29, 2021
Inman Digital Clear Aligners
K210763 · NXC
Inman Orthodontic Laboratories, Inc.
Dental · 198d
Cleared Sep 24, 2021
Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
K212125 · DZE
Nobel Biocare AG
Dental · 79d
Cleared Sep 24, 2021
Dynamic TiBase
K212108 · NHA
Talladium Espa?a, SL
Dental · 80d
Cleared Sep 23, 2021
ABC Dental Implant System
K202092 · DZE
Abracadabra Implants , Ltd.
Dental · 422d
Cleared Sep 22, 2021
Smylio Invisible Clear Aligners
K212660 · NXC
Smylio, Inc.
Dental · 30d
Cleared Sep 22, 2021
ACTIVA PRESTO PACK
K210045 · EBF
Pulpdent Corporation
Dental · 257d
Cleared Sep 20, 2021
SMILERS
K212961 · NXC
Biotech Dental Smilers, Sas
Dental · 4d
Cleared Sep 17, 2021
NTI ClenchGuard
K211158 · OBR
Boyd Research, Inc.
Dental · 151d
Cleared Sep 17, 2021
Syntec Orthodontic Mini Screw Extended System
K202790 · OAT
Syntec Scientific Corporation
Dental · 360d
Cleared Sep 16, 2021
BioRoot Flow 0.5g, BioRoot Flow 2g
K212283 · KIF
Septodont
Dental · 57d
Cleared Sep 15, 2021
TruAbutment DS, TruBase
K203649 · NHA
Truabutment, Inc.
Dental · 275d
Cleared Sep 10, 2021
s-Clean Pre-Milled Abutment Mini
K210410 · NHA
Dentis Co., Ltd.
Dental · 211d
Cleared Sep 09, 2021
EPIEN Dental Cleanser
K201785 · KJJ
Epien Medical, Inc.
Dental · 436d
Cleared Sep 03, 2021
LuxaPrint Ortho Plus
K210940 · MQC
Dmg Digital Enterprises SE
Dental · 158d
Cleared Sep 03, 2021
Dental Low-speed Handpieces and Accessories
K202786 · EFB
Microp Technology (Taiwan), Inc.
Dental · 346d
Cleared Sep 03, 2021
Dentilube Spray
K202689 · LFD
Oxy2plus, LLC
Dental · 353d