FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,611 results
865–888 of 12,611
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