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
289–312 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Aug 18, 2025
Neodent Implant System - Zirconia Implant System
K250271 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 200d
Cleared Aug 14, 2025
Geistlich Bio-Gide
K251062 · NPL
Geistlich Pharma AG
Dental · 132d
Cleared Aug 13, 2025
Bone Screw
K251569 · DZL
Osstem Implant Co., Ltd.
Dental · 83d
Cleared Aug 13, 2025
S.I.N. Dental Implant System
K251046 · DZE
S.I.N. Implant System Ltda
Dental · 132d
Cleared Aug 12, 2025
Straumann® RidgeFit Implants
K250294 · DZE
Institut Straumann AG
Dental · 193d
Cleared Aug 08, 2025
Parkell Pit and Fissure Sealant
K243254 · EBC
Parkell, Inc.
Dental · 297d
Cleared Aug 01, 2025
NOBILCAM IMPAK Disc
K251252 · MQC
Shandong Huge Dental Material...
Dental · 100d
Cleared Aug 01, 2025
QuickSleeper 5
K243427 · EGM
Dentalhitec
Dental · 269d