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FDA 510(k)

Polibond

K-Number: K232691 · 2023-09-05

ApplicantZirkonzahn Srl
Decision Date2023-09-05
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Polibond is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn Srl. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K232691. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polibond?

Polibond is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Zirkonzahn Srl. The 510(k) number is K232691.

When did Polibond receive FDA 510(k) clearance?

Polibond received FDA 510(k) clearance on 2023-09-05, under 510(k) number K232691.

Who is the listed applicant for Polibond?

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

What is the FDA product code for Polibond?

The FDA product code for Polibond is EBI.

Other records listing Zirkonzahn Srl as applicant

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Related Devices (Code: EBI)

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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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