Polibond
K-Number: K232691 · 2023-09-05
ApplicantZirkonzahn Srl
Decision Date2023-09-05
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Polibond is a medical device manufactured by Zirkonzahn Srl. It received FDA 510(k) clearance on 2023-09-05 under approval 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. It is manufactured by Zirkonzahn Srl. The 510(k) number is K232691.
When was Polibond approved by the FDA?
Polibond received FDA 510(k) clearance on 2023-09-05, under approval number K232691.
What company makes Polibond?
Polibond is manufactured by Zirkonzahn Srl.
What is the FDA product code for Polibond?
The FDA product code for Polibond is 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.