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
409–432 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 04, 2025
iPhysio® System
K232383 · NHA
Euroteknika
Dental · 574d
Cleared Feb 28, 2025
Synea Fusion Handpieces (Intensiv & Profin)
K242179 · EFB
W&H Dentalwerk B?rmoos GmbH
Dental · 218d
Cleared Feb 28, 2025
Silver Fluoride Hypersensitivity Varnish
K241041 · PHR
Young Dental Manufacturing Co. 1, LLC
Dental · 318d
Cleared Feb 25, 2025
BruxZir® Esthetic NOW
K250223 · EIH
Prismatik Dentalcraft, Inc.
Dental · 29d
Cleared Feb 24, 2025
SD Implant System
K241703 · DZE
Arum Dentistry Co., Ltd.
Dental · 256d
Cleared Feb 21, 2025
TEMP MASTER, PMMA-based dental resin
K243951 · EBG
Taiwan Dental Materials Co., Ltd.
Dental · 60d
Cleared Feb 21, 2025
VITA YZ Multi Translucent
K243940 · EIH
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 63d
Cleared Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637 · DZJ
Materialise NV
Dental · 88d
Cleared Feb 21, 2025
Custom Abutments
K243278 · NHA
Institut Straumann AG
Dental · 128d
Cleared Feb 21, 2025
Synthetic Bone Graft Particulate
K241186 · LYC
Shenzhen Dazhou Medical Technology...
Dental · 298d
Cleared Feb 20, 2025
SparkTM Clear Aligner System
K250487 · NXC
Ormco Corporation
Dental · 1d
Cleared Feb 19, 2025
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
K250473 · EIA
Dci International, LLC
Dental
Cleared Feb 19, 2025
Straumann InLab Validated Workflow
K243478 · NHA
Institut Straumann AG
Dental · 103d
Cleared Feb 14, 2025
DESS Dental Smart Solutions
K243212 · NHA
Terrats Medical SL
Dental · 135d
Cleared Feb 13, 2025
AH Plus Endodontic Sealer
K243546 · KIF
Dentsply Sirona, Inc.
Dental · 90d
Cleared Feb 13, 2025
Integrated Endo System (Meet Endo-II)
K242317 · ELC
Denjoy Dental Co., Ltd.
Dental · 192d
Cleared Feb 11, 2025
LONGY Implant and LONGY-N Implant
K241462 · DZE
Noris Medical , Ltd.
Dental · 264d
Cleared Feb 10, 2025
Remi Custom Night Guard
K243516 · MQC
Grindguard, Inc.
Dental · 89d
Cleared Feb 07, 2025
Any-Com Bulk
K242713 · EBF
Mediclus Co., Ltd.
Dental · 151d
Cleared Feb 07, 2025
BDC Dental Unit
K242404 · EIA
Bdc Dental Corporation , Ltd.
Dental · 178d
Cleared Jan 29, 2025
Surcam Dental Implant System
K242217 · DZE
Surcam Medical Devices and...
Dental · 184d
Cleared Jan 27, 2025
Firstar Dental Unit
K231297 · EIA
Firstar Dental Company
Dental · 634d
Cleared Jan 17, 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · LQY
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 126d
Cleared Jan 17, 2025
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)
K242064 · NHA
Smart Denture Conversions, LLC
Dental · 186d