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
697–720 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Feb 02, 2024
Myoaligner Appliance
K230548 · MQC
Myohealth Technologies, LLC
Dental · 339d
Cleared Jan 26, 2024
One-Fil
K232182 · KIF
Mediclus Co., Ltd.
Dental · 186d
Cleared Jan 24, 2024
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
K233208 · NHA
Nobel Biocare AB
Dental · 118d
Cleared Jan 23, 2024
Chemo Mouthpiece
K232917 · QUA
Chemo Mouthpiece, LLC
Dental · 126d
Cleared Jan 23, 2024
Dental Porcelain Powder
K232676 · EIH
Chengdu Besmile Medical Technology...
Dental · 144d
Cleared Jan 23, 2024
Dental Glass Ceramics
K232673 · EIH
Chengdu Besmile Medical Technology...
Dental · 144d
Cleared Jan 23, 2024
Endoform Dental Membrane
K231305 · NPL
Aroa Biosurgery , Ltd.
Dental · 263d
Cleared Jan 22, 2024
MegaGen Dental Implant Abutment - Scan Healing Abutment
K233450 · NHA
Megagen Implant Co., Ltd.
Dental · 94d
Cleared Jan 18, 2024
LuxCreo Dental Night Guard Resin
K230592 · MQC
LuxCreo, Inc.
Dental · 321d
Cleared Jan 18, 2024
S-Plant Dental Implant System
K221866 · DZE
Newton Implant Systems, Inc.
Dental · 570d
Cleared Jan 16, 2024
Aniti-Snore Mouthguard+
K231138 · LRK
Oscimed SA
Dental · 270d
Cleared Jan 13, 2024
Stryker Facial iD System
K232350 · JEY
Stryker Craniomaxillofacial
Dental · 159d
Cleared Jan 12, 2024
Zirconia Block
K233125 · EIH
Hangzhou Ivista Medical Devices Co.,...
Dental · 107d
Cleared Jan 12, 2024
Ti Link Abutment
K232170 · NHA
Izenimplant Co., Ltd.
Dental · 175d
Cleared Jan 11, 2024
Clevaligner Software (V1.0.0)
K233616 · PNN
Clevaligner, Ltd.
Dental · 59d
Cleared Jan 05, 2024
DESS Dental Smart Solutions
K233316 · NHA
Terrats Medical SL
Dental · 98d
Cleared Jan 05, 2024
Fusion Core DC Flo
K231263 · EBF
Prevest Denpro Limited
Dental · 248d
Cleared Jan 04, 2024
Anthogyr FlexiBase® titanium bases for Axiom® BL
K231072 · NHA
Anthogyr
Dental · 265d
Cleared Dec 29, 2023
URIS Smart Path Implant System & Prosthetic
K230438 · DZE
Truabutment, Inc.
Dental · 311d
Cleared Dec 29, 2023
UniFit Dental Implant System
K223714 · DZE
Adin Dental Implant Systems , Ltd.
Dental · 382d
Cleared Dec 22, 2023
3M™ Transbond™ Orthodontic Adhesive
K234043 · DYH
3M Unitek Orthodontic Products
Dental · 1d
Cleared Dec 22, 2023
TopCEM Dual Cure Resin Cement
K233082 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 87d
Cleared Dec 22, 2023
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · LQY
Changzhou Haili Medical Co., Ltd.
Dental · 108d
Cleared Dec 21, 2023
Dental Glass Ceramics
K233016 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 90d