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
841–864 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Apr 13, 2023
Point implant system
K222738 · DZE
Pointnix Co., Ltd.
Dental · 216d
Cleared Apr 06, 2023
ACRIFIX
K230341 · EBI
Deltamed GmbH
Dental · 57d
Cleared Apr 06, 2023
S.I.N. Dental Implant System
K230069 · NHA
S.I.N. ? Sistema DE Implante Nacional...
Dental · 86d
Cleared Apr 05, 2023
Nightwear Aligners
K221537 · NXC
Smylio, Inc.
Dental · 313d
Cleared Apr 05, 2023
N2
K211556 · EIA
Megagen Implant Co., Ltd.
Dental · 686d
Cleared Apr 03, 2023
G7, Dental Operative Unit and Accessories
K213749 · EIA
Shinhung Company, Ltd.
Dental · 489d
Cleared Mar 31, 2023
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K230003 · EIH
Topzir Biotech Co., Ltd.
Dental · 87d
Cleared Mar 27, 2023
RODIN Palette Naturalizing Kit
K223365 · EBD
Belport Company, Inc., Gingi-Pak
Dental · 144d
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