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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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2024-04-02 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K240888.

When did Calibra Abutment Resin Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for Calibra Abutment Resin Cement?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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