FDA 510(k)

DD Hybridlayer (multicolored zirconia)

K-Number: K241579 · 2024-09-06

Decision Date2024-09-06

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DD Hybridlayer (multicolored zirconia) is a medical device manufactured by Dental Direkt GmbH. It received FDA 510(k) clearance on 2024-09-06 under approval number K241579. 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 DD Hybridlayer (multicolored zirconia)?

DD Hybridlayer (multicolored zirconia) is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Dental Direkt GmbH. The 510(k) number is K241579.

When was DD Hybridlayer (multicolored zirconia) approved by the FDA?

DD Hybridlayer (multicolored zirconia) received FDA 510(k) clearance on 2024-09-06, under approval number K241579.

What company makes DD Hybridlayer (multicolored zirconia)?

DD Hybridlayer (multicolored zirconia) is manufactured by Dental Direkt GmbH.

What is the FDA product code for DD Hybridlayer (multicolored zirconia)?

The FDA product code for DD Hybridlayer (multicolored zirconia) 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.