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
481–504 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Oct 24, 2024
KeyPrint KeyDenture Base
K241089 · EBI
Keystone Industries
Dental · 188d
Cleared Oct 23, 2024
Immediate Molar Implants
K241753 · DZE
Biomet 3i, LLC
Dental · 127d
Cleared Oct 21, 2024
Dynamic TiBase
K241170 · NHA
Talladium Espa?a, SL
Dental · 178d
Cleared Oct 18, 2024
Dental Barrier and Sleeves
K242435 · PEM
Wellmed Dental Medical Supply Co., Ltd.
Dental · 63d
Cleared Oct 18, 2024
edelweiss CAD/CAM T-BLOCK
K241131 · EBF
Edelweiss Dentistry Products GmbH
Dental · 177d
Cleared Oct 18, 2024
PreXolid CAD/CAM abutments
K240725 · NHA
Eclectic Co., Ltd.
Dental · 214d
Cleared Oct 18, 2024
Vittra APS Unique Flow
K232994 · EBF
Dentscare Ltda
Dental · 392d
Cleared Oct 17, 2024
MP Pin flat without thread (36BMP000020/MP20)
K240321 · DZL
Hager& Meisinger GmbH
Dental · 258d