ICE Ceramics, ICE Stains, Fresco
K-Number: K213722 · 2022-12-14
ApplicantZirkonzahn Srl
Decision Date2022-12-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ICE Ceramics, ICE Stains, Fresco is a medical device manufactured by Zirkonzahn Srl. It received FDA 510(k) clearance on 2022-12-14 under approval number K213722. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ICE Ceramics, ICE Stains, Fresco?
ICE Ceramics, ICE Stains, Fresco is a medical device that received FDA 510(k) clearance on 2022-12-14. It is manufactured by Zirkonzahn Srl. The 510(k) number is K213722.
When was ICE Ceramics, ICE Stains, Fresco approved by the FDA?
ICE Ceramics, ICE Stains, Fresco received FDA 510(k) clearance on 2022-12-14, under approval number K213722.
What company makes ICE Ceramics, ICE Stains, Fresco?
ICE Ceramics, ICE Stains, Fresco is manufactured by Zirkonzahn Srl.
What is the FDA product code for ICE Ceramics, ICE Stains, Fresco?
The FDA product code for ICE Ceramics, ICE Stains, Fresco is EIH.
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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.