FDA 510(k)

3Delta UNlimited

K-Number: K243720 · 2024-12-18

Decision Date2024-12-18

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

3Delta UNlimited is a medical device manufactured by Deltamed GmbH. It received FDA 510(k) clearance on 2024-12-18 under approval number K243720. 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 UNlimited?

3Delta UNlimited is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Deltamed GmbH. The 510(k) number is K243720.

When was 3Delta UNlimited approved by the FDA?

3Delta UNlimited received FDA 510(k) clearance on 2024-12-18, under approval number K243720.

What company makes 3Delta UNlimited?

3Delta UNlimited is manufactured by Deltamed GmbH.

What is the FDA product code for 3Delta UNlimited?

The FDA product code for 3Delta UNlimited is EBF.

Other Devices by Deltamed GmbH

K200039P pro Crown & Bridge K2118043Delta Crown K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix K230341ACRIFIX

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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.