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
217–240 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Sep 17, 2025
DENTURE SOFT EX (Pink set)
K252035 · EBI
Kamemizu Chemical Industry Co., Ltd.
Dental · 79d
Cleared Sep 17, 2025
FG Bone Graft M
K244006 · LYC
Full Golden Biotech Co., Ltd.
Dental · 265d
Cleared Sep 17, 2025
Double Tube Herbst Appliance
K243752 · LRK
The Tmj Clinic PC
Dental · 286d
Cleared Sep 16, 2025
SFIT Abutment
K242287 · NHA
Cowellmedi Co., Ltd.
Dental · 410d
Cleared Sep 15, 2025
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · EGS
Premium Plus (Dongguan) Limited
Dental · 89d
Cleared Sep 11, 2025
Nylon flexTAP(R)
K252374 · LRK
Airway Technologies D/B/A Airway...
Dental · 43d
Cleared Sep 11, 2025
Serafin®
K251758 · NXC
Tns Co., Ltd.
Dental · 94d
Cleared Sep 04, 2025
Oniris
K250353 · LRK
Oniris
Dental · 209d
Cleared Sep 03, 2025
BruxZir® NOW
K252446 · EIH
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared Sep 02, 2025
RODIN Cement
K251775 · EMA
Belport Company, Inc., Gingi-Pak
Dental · 84d
Cleared Sep 02, 2025
Customized Abutment and Screw
K242768 · NHA
Chengdu Besmile Medical Technology...
Dental · 354d
Cleared Aug 29, 2025
Invisalign System
K252380 · NXC
Align Technology, Inc.
Dental · 30d
Cleared Aug 29, 2025
G aenial Universal Injectable II
K251946 · EBF
GC America, Inc.
Dental · 65d
Cleared Aug 29, 2025
Primescan 2
K250771 · NTK
Dentsply Sirona, Inc.
Dental · 169d
Cleared Aug 29, 2025
FG Bone Graft B
K243745 · LYC
Full Golden Biotech Corporation
Dental · 267d
Cleared Aug 27, 2025
Additively Manufactured Aligner Resin
K251415 · NXC
Aidite (Qinhuangdao) Technology Co.,...
Dental · 112d
Cleared Aug 25, 2025
Motor and Apex Module (MaAM)
K251811 · EBW
Dentsply Sirona, Inc.
Dental · 74d
Cleared Aug 25, 2025
DenMat Multilayered Zirconia Disc
K251593 · EIH
Denmat Holding, LLC
Dental · 90d
Cleared Aug 25, 2025
NobelZygoma TiUltra Implant system
K243834 · DZE
Nobel Biocare AB
Dental · 255d
Cleared Aug 22, 2025
One-Fil Putty Injectable
K251884 · KIF
Mediclus Co., Ltd.
Dental · 63d
Cleared Aug 22, 2025
EnDrive (EnDriveUS)
K243692 · EKX
Advanced Technology Research (A.T.R.)...
Dental · 266d
Cleared Aug 21, 2025
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS...
K251647 · DZE
Dentsply Sirona, Inc.
Dental · 84d
Cleared Aug 20, 2025
IPD Dental Implant Abutments
K251471 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Aug 20, 2025
LOCATOR® Angled Abutment
K250721 · NHA
Zest Anchors, LLC
Dental · 163d