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
889–912 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Dec 30, 2022
CMFlexTM
K213260 · LYC
Dimension Inx Corp.
Dental · 456d
Cleared Dec 29, 2022
BioClean Implant Restorative System
K222984 · NHA
Bioclean Dental, LLC
Dental · 92d
Cleared Dec 22, 2022
Coltolux Comfort LED Curing Light
K223142 · EBZ
Dent4you AG
Dental · 79d
Cleared Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
K222894 · NXC
Align Technology, Inc.
Dental · 90d
Cleared Dec 21, 2022
CURA-Temp
K202965 · EBG
Mgnewton , Ltd.
Dental · 812d
Cleared Dec 20, 2022
Al Smile Aligner
K222308 · NXC
Nanjing Jiahe Dental Technology Co.,...
Dental · 141d
Cleared Dec 20, 2022
IBS System
K220517 · DZE
Innobiosurg Co., Ltd.
Dental · 300d
Cleared Dec 20, 2022
Bonafix 2 Plus
K213677 · DZE
Zentek Medical, LLC
Dental · 393d