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
337–360 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 31, 2025
Denture Base Resin DT20
K250946 · EBI
Hangzhou SHINING3D Dental Technology...
Dental · 3d
Cleared Mar 21, 2025
ChecQ (AC100)
K241065 · EKX
Dentis Co., Ltd.
Dental · 337d
Cleared Mar 18, 2025
Hard Splint & Thermo-Adaptive Splint
K241729 · MQC
Whip Mix Corporation
Dental · 277d
Cleared Mar 14, 2025
Visalys® Bulk Fill 1 x 4 g Syringe (15060)
K250267 · EBF
Kettenbach GmbH & Co. KG
Dental · 43d
Cleared Mar 14, 2025
Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
K250025 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 67d
Cleared Mar 14, 2025
One-Fil Putty
K243353 · KIF
Mediclus Co., Ltd.
Dental · 136d
Cleared Mar 07, 2025
Geistlich Bio-Flow®
K242510 · NPM
Geistlich Pharma AG
Dental · 196d
Cleared Mar 07, 2025
Apex Locator
K242383 · LQY
Shenzhen Rogin Medical Co., Ltd.
Dental · 207d
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