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
913–936 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Mar 27, 2023
XT Stain/Glaze
K223192 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 165d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 23, 2023
SAVE GBR
K222367 · DZL
Dentis Co., Ltd.
Dental · 230d
Cleared Mar 23, 2023
Endo Ultrasonic Activator
K222096 · ELC
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 248d
Cleared Mar 23, 2023
Implant-One Multi-Unit Abutment
K212394 · NHA
Implant Logistics, Inc.
Dental · 598d
Cleared Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K221402 · NHA
Dentsply Sirona, Inc.
Dental · 310d
Cleared Mar 18, 2023
InterOss Collagen
K221808 · NPM
Sigmagraft, Inc.
Dental · 269d
Cleared Mar 17, 2023
Denture Base Resin
K230115 · EBI
Aidite (Qinhuangdao) Technology Co.,...
Dental · 59d
Cleared Mar 16, 2023
Ensmile
K222619 · NXC
Ensmile Pvt, Ltd.
Dental · 198d
Cleared Mar 09, 2023
DESS Dental Smart Solutions
K221301 · NHA
Terrats Medical SL
Dental · 308d
Cleared Mar 08, 2023
Dental Ceramic Blocks
K223742 · EBF
Aidite (Qinhuangdao) Technology Co.,...
Dental · 84d
Cleared Mar 07, 2023
MedCAD AccuPlan System
K223024 · DZJ
Medcad
Dental · 159d
Cleared Mar 06, 2023
Provata Implant System
K222457 · DZE
Southern Implants (Pty), Ltd.
Dental · 203d
Cleared Mar 06, 2023
LC ChromeFlow
K222445 · EBF
S&C Polymer Silicon- Und Composite...
Dental · 203d
Cleared Mar 03, 2023
EZ Bond Universal
K230009 · KLE
Meta Biomed Co., Ltd.
Dental · 59d
Cleared Feb 27, 2023
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
K223253 · EIH
Arum Dentistry Co., Ltd.
Dental · 129d
Cleared Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845 · NXC
Blue Sky Bio, LLC
Dental · 245d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554 · NPK
Cowellmedi Co., Ltd.
Dental · 646d
Cleared Feb 22, 2023
TRAUS Air Dental Handpiece
K221741 · EFB
Saeshin Precision Co., Ltd.
Dental · 252d
Cleared Feb 17, 2023
Glidewell TuffSplint™ Appliance Resin
K223798 · MQC
Prismatik Dentalcraft, Inc.
Dental · 60d
Cleared Feb 16, 2023
PMMA Blocks for Dental Use
K223477 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 90d
Cleared Feb 14, 2023
Endocem MTA Premixed Regular
K213757 · KIF
Maruchi
Dental · 441d
Cleared Feb 10, 2023
Glass Ceramic
K223194 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 120d
Cleared Feb 10, 2023
Glass Ceramics
K222513 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 175d