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FDA 510(k)

3Delta Crown

K-Number: K211804 · 2021-12-06

ApplicantDeltamed GmbH
Decision Date2021-12-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3Delta Crown is a medical device manufactured by Deltamed GmbH. It received FDA 510(k) clearance on 2021-12-06 under approval number K211804. 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 3Delta Crown?

3Delta Crown is a medical device that received FDA 510(k) clearance on 2021-12-06. It is manufactured by Deltamed GmbH. The 510(k) number is K211804.

When was 3Delta Crown approved by the FDA?

3Delta Crown received FDA 510(k) clearance on 2021-12-06, under approval number K211804.

What company makes 3Delta Crown?

3Delta Crown is manufactured by Deltamed GmbH.

What is the FDA product code for 3Delta Crown?

The FDA product code for 3Delta Crown is EBF.

Other Devices by Deltamed GmbH

K200039P pro Crown & Bridge K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix K230341ACRIFIX K2437203Delta UNlimited

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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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