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
793–816 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 07, 2023
Cleo
K232011 · NJM
American Orthodontics
Dental · 1d
Cleared Jul 07, 2023
IH Implant System
K222707 · DZE
Sewonmedix, Inc.
Dental · 303d
Cleared Jul 03, 2023
Dental Lithium Disilicate Glass-Ceramic
K230487 · EIH
Fuzhou Rick Brown Biomaterials Co., Ltd.
Dental · 130d
Cleared Jul 01, 2023
NB Implant System
K230725 · DZE
Arum Dentistry Co., Ltd.
Dental · 107d
Cleared Jun 30, 2023
Easy On Universal Glaze & Stain
K231264 · EIH
Doctus Global
Dental · 59d
Cleared Jun 26, 2023
Z7 Zirconia Implant System
K221488 · DZE
Z7, LLC
Dental · 399d
Cleared Jun 24, 2023
BR SLA Type Implant System
K222142 · DZE
Biotem Co., Ltd.
Dental · 339d
Cleared Jun 23, 2023
DD medical polymers (PMMA)
K230410 · EBI
Dental Direkt GmbH
Dental · 128d
Cleared Jun 23, 2023
TECHFIT DISRP® System
K230276 · DZJ
Techfit Digital Surgery
Dental · 142d
Cleared Jun 23, 2023
Neodent Implant System - Helix Short Implant System
K223638 · DZE
Jjgc Industria E Comercio DE...
Dental · 200d
Cleared Jun 23, 2023
Black Diamond
K222323 · PHR
Elevate Oral Care, LLC
Dental · 325d
Cleared Jun 22, 2023
Straumann SLActive labeling changes
K223083 · DZE
Institut Straumann AG
Dental · 265d
Cleared Jun 20, 2023
SMARTbase Abutment System
K223535 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 209d
Cleared Jun 20, 2023
Perfit CL
K223029 · EIH
Vatech Mcis Co., Ltd.
Dental · 264d
Cleared Jun 14, 2023
IR SLA Type Implant System
K222144 · DZE
Biotem Co., Ltd.
Dental · 329d
Cleared Jun 13, 2023
iOrtho
K223518 · PNN
Shanghai EA Medical Instruments Co.,...
Dental · 202d
Cleared Jun 13, 2023
Clear Aligner
K223517 · NXC
Wuxi EA Medical Instruments...
Dental · 202d
Cleared Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
K231347 · EIH
Prismatik Dentalcraft, Inc.
Dental · 31d
Cleared Jun 09, 2023
OrthoPulse 2.0E (OPi2E-100)
K230905 · PLH
Biolux Technology GmbH
Dental · 70d
Cleared Jun 08, 2023
SNUCONE Tissue Level Implant System
K222792 · DZE
Snucone Co., Ltd.
Dental · 265d
Cleared Jun 06, 2023
A-Line Advanced
K231635 · NJM
Biocetec Co., Ltd.
Dental · 1d
Cleared Jun 05, 2023
DynaFlex Clear Brackets & Buttons
K230225 · NJM
Dyna Flex
Dental · 129d
Cleared Jun 04, 2023
Stella
K221752 · DZE
Shinhung Mst Co., Ltd.
Dental · 353d
Cleared Jun 02, 2023
Titanium Turbine
K230888 · EFB
Nakanishi, Inc.
Dental · 63d