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FDA 510(k)

Calibra Abutment Resin Cement

K-Number: K240888 · 2024-04-02

ApplicantDentsply Sirona
Decision Date2024-04-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Calibra Abutment Resin Cement is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2024-04-02 under approval number K240888. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Calibra Abutment Resin Cement?

Calibra Abutment Resin Cement is a medical device that received FDA 510(k) clearance on 2024-04-02. It is manufactured by Dentsply Sirona. The 510(k) number is K240888.

When was Calibra Abutment Resin Cement approved by the FDA?

Calibra Abutment Resin Cement received FDA 510(k) clearance on 2024-04-02, under approval number K240888.

What company makes Calibra Abutment Resin Cement?

Calibra Abutment Resin Cement is manufactured by Dentsply Sirona.

What is the FDA product code for Calibra Abutment Resin Cement?

The FDA product code for Calibra Abutment Resin Cement is EMA.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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