FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,595 results
865–888 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845 · NXC
Blue Sky Bio, LLC
Dental · 245d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554 · NPK
Cowellmedi Co., Ltd.
Dental · 646d
Cleared Feb 22, 2023
TRAUS Air Dental Handpiece
K221741 · EFB
Saeshin Precision Co., Ltd.
Dental · 252d
Cleared Feb 17, 2023
Glidewell TuffSplint™ Appliance Resin
K223798 · MQC
Prismatik Dentalcraft, Inc.
Dental · 60d
Cleared Feb 16, 2023
PMMA Blocks for Dental Use
K223477 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 90d
Cleared Feb 14, 2023
Endocem MTA Premixed Regular
K213757 · KIF
Maruchi
Dental · 441d
Cleared Feb 10, 2023
Glass Ceramic
K223194 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 120d
Cleared Feb 10, 2023
Glass Ceramics
K222513 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 175d
Cleared Feb 09, 2023
Toothsi, Smilealigners
K223338 · NXC
Makeo Healthcare Technologies Private...
Dental · 100d
Cleared Feb 07, 2023
SAVE GBR
K222451 · NHA
Dentis Co., Ltd.
Dental · 176d
Cleared Feb 06, 2023
3M™ VitCal Liner/Base
K230270 · EJK
3M Espe Dental Products
Dental · 6d
Cleared Feb 03, 2023
Luna Dental Implant System
K223395 · NHA
Shinhung Mst Co., Ltd.
Dental · 87d
Cleared Feb 02, 2023
Implant Direct Dental Implant Systems Portfolio - MR Conditional
K222211 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 192d
Cleared Jan 19, 2023
No Stress Impress
K213175 · ELW
No Stress Impress, LLC
Dental · 478d
Cleared Jan 18, 2023
eXciteOSA without remote control (3000)
K223446 · QNO
Signifier Medical Technologies, Ltd.
Dental · 64d
Cleared Jan 13, 2023
s-Clean Link Abutment
K222913 · NHA
Dentis Co., Ltd.
Dental · 109d
Cleared Jan 13, 2023
S-Mono
K221317 · DZE
Shinhung Mst Co., Ltd.
Dental · 252d
Cleared Jan 13, 2023
Silk’n Toothwave
K214078 · QMJ
Home Skinovations , Ltd.
Dental · 382d
Cleared Jan 12, 2023
MU System
K222976 · NHA
Dentis Co., Ltd.
Dental · 106d
Cleared Jan 12, 2023
Rainbow 360
K222830 · KLE
Kerr Corporation
Dental · 115d
Cleared Jan 11, 2023
DD Solid Connect® CAD/CAM Abutments
K191111 · NHA
Dental Direkt GmbH
Dental · 1356d
Cleared Jan 06, 2023
BLUEDIAMOND IMPLANT, Abutment Screw
K211812 · DZE
Megagen Implant Co., Ltd.
Dental · 574d
Cleared Jan 04, 2023
OnyxCeph
K213263 · LLZ
Image Instruments GmbH
Dental · 461d
Cleared Dec 30, 2022
DNA Appliance
K222872 · LRK
Vivos Therapeutics, Inc.
Dental · 99d