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
937–960 of 12,659
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