FDA.report

510(k) K242366

Device
OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
Applicant
Overfibers S.R.L.
510(k) number
K242366
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-10
Date received
2024-08-09
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Castrenze Genovese
Address
Via Malatesta,7 Imola (Bo) IT 40026 40026

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
08059388443307NeobondOVERFIBERS SRL2025-08-26
08059388440115OverCEM SA Opaque Starter KitOVERFIBERS SRL2025-02-24
08059388440108OverCEM SA Universal Starter KitOVERFIBERS SRL2025-02-24
08059388440092OverCEM SA Translucent Starter KitOVERFIBERS SRL2025-02-24
08059388440085OverCEM SA Starter KitOVERFIBERS SRL2025-02-24
08059388440078OverCEM Cer-Abutment Starter KitOVERFIBERS SRL2025-02-24
08059388440061OverCEM Ti-Abutment Starter KitOVERFIBERS SRL2025-02-24
08059388440054OverCEM Cer-AbutmentOVERFIBERS SRL2025-02-21
08059388440047OverCEM Ti-AbutmentOVERFIBERS SRL2025-02-21
08059388440030OverCEM SA Translucent OVERFIBERS SRL2025-02-21
08059388440023OverCEM SA Opaque OVERFIBERS SRL2025-02-21
08059388440016OverCEM SA UniversalOVERFIBERS SRL2025-02-21

Other 510(k) Records For Product Code EMA

510(k)DeviceApplicantDecision date
K253337REGEN Bioactive CementInter-Med, Inc.2026-04-15
K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH2026-03-20
K254063iCEM Universal PlusKulzer, LLC2025-12-19
K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.2025-12-12
K252808GlasIonomer FX-LCShofu Dental Corporation2025-12-09
K252165ZIRCONOMER PShofu Dental Corporation2025-10-28
K250953EQUIA LC ONEGC America, Inc.2025-09-19
K251775RODIN CementBelport Company, Inc., Gingi-Pak2025-09-02
K251470ResiCem EXShofu Dental Corporation2025-07-11
K250156Choice 2 DCBisco, Inc.2025-07-11
K250566EsCem RMGISpident Co., Ltd.2025-06-20
K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.2024-07-24
K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd.2024-06-28
K240888Calibra Abutment Resin CementDentsply Sirona2024-04-02
K233161BeautiLink SAShofu Dental Corporation2023-09-28