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
841–864 of 12,659
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