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
409–432 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 27, 2024
C&B Ceramic
K233273 · EBF
Prevest Denpro Limited
Dental · 425d
Cleared Nov 26, 2024
Digital Temp
K242559 · EBG
Sprintray, Inc.
Dental · 90d
Cleared Nov 26, 2024
PrimmaArt
K231859 · EBG
Dentscare Ltda
Dental · 522d
Cleared Nov 25, 2024
Customized Abutment
K242245 · NHA
Arum Dentistry Co., Ltd.
Dental · 117d
Cleared Nov 25, 2024
MIS LYNX Conical Connection Implant System
K241692 · DZE
Dentsply Sirona, Inc.
Dental · 166d
Cleared Nov 22, 2024
Jasmate® Toothpaste
K242913 · LBH
Jasberry Healthcare Private Limited
Dental · 59d
Cleared Nov 22, 2024
Additively Manufactured Denture Resin
K242884 · EBI
Aidite (Qinhuangdao) Technology Co.,...
Dental · 60d
Cleared Nov 20, 2024
Estar-ZE
K242521 · EIH
Osstem Implant Co., Ltd.
Dental · 89d
Cleared Nov 15, 2024
Speedex Light Body
K242360 · ELW
Dent4you AG
Dental · 98d
Cleared Nov 15, 2024
NUVENTUS NV.C™ Dental Implant System
K233081 · DZE
Infinitum Eta, Ltd.
Dental · 416d
Cleared Nov 13, 2024
Dental Glass Ceramics Blocks (HT, LT, MT)
K242407 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 91d
Cleared Nov 13, 2024
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW,...
K240337 · EFB
Guangdong Jinme Medical Technology...
Dental · 282d
Cleared Nov 12, 2024
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22),...
K241074 · EFB
Foshan Soco Precision Instrument Co.,...
Dental · 207d
Cleared Nov 11, 2024
Straumann® Anatomic Healing Abutments XC (AHA)
K241575 · NHA
Straumann USA, LLC
Dental · 161d
Cleared Nov 08, 2024
TopCEM Ceramic Primer Ceramic Coupling Agent
K242749 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 57d
Cleared Nov 07, 2024
VioSeal
K242702 · KIF
Spident Co., Ltd.
Dental · 59d
Cleared Nov 07, 2024
LL Implant System
K242379 · DZE
Ossvis Co., Ltd.
Dental · 87d
Cleared Nov 06, 2024
Accelx Implant System
K242261 · DZE
Biotech Dental, LLC
Dental · 98d
Cleared Nov 05, 2024
DESS Dental Smart Solutions
K242340 · NHA
Terrats Medical SL
Dental · 90d
Cleared Nov 01, 2024
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37...
K242675 · KLE
Spident Co., Ltd.
Dental · 56d
Cleared Oct 31, 2024
Highness Implant System
K240383 · DZE
Highness Co., Ltd.
Dental · 266d
Cleared Oct 30, 2024
ZENEX Implant System_Long
K240560 · DZE
Izenimplant Co., Ltd.
Dental · 244d
Cleared Oct 24, 2024
CEREC Cercon 4D CAD/CAM Blocks
K242462 · EIH
Dentsply Sirona
Dental · 66d
Cleared Oct 24, 2024
ArgenZ MTZ
K242458 · EIH
Argen Corporation
Dental · 66d