FDA.report

510(k) K240888

Device
Calibra Abutment Resin Cement
Applicant
Dentsply Sirona
510(k) number
K240888
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-02
Date received
2024-04-01
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
Y

Related Records

Applicant Contact

Contact
Rebecca Sporer
Address
221 W. Philadelphia St. Suite 60w York PA US 17401 17401

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EMA

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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
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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
K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L.2025-01-10
K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.2024-07-24
K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd.2024-06-28
K233161BeautiLink SAShofu Dental Corporation2023-09-28