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FDA 510(k)

Saremco Print CROWNTEC

K-Number: K213343 · 2022-01-21

Decision Date2022-01-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Saremco Print CROWNTEC is a medical device manufactured by Saremco Dental AG. It received FDA 510(k) clearance on 2022-01-21 under approval number K213343. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saremco Print CROWNTEC?

Saremco Print CROWNTEC is a medical device that received FDA 510(k) clearance on 2022-01-21. It is manufactured by Saremco Dental AG. The 510(k) number is K213343.

When was Saremco Print CROWNTEC approved by the FDA?

Saremco Print CROWNTEC received FDA 510(k) clearance on 2022-01-21, under approval number K213343.

What company makes Saremco Print CROWNTEC?

Saremco Print CROWNTEC is manufactured by Saremco Dental AG.

What is the FDA product code for Saremco Print CROWNTEC?

The FDA product code for Saremco Print CROWNTEC is EBF.

Other Devices by Saremco Dental AG

Related Devices (Code: EBF)

Official Source

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