Calibra Abutment Resin Cement— 510(k) K240888

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K240888 for Calibra Abutment Resin Cement, Substantially Equivalent on 2024-04-02. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2024-04-01
Decision date: 2024-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.