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FDA 510(k)

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

K-Number: K222741 · 2022-11-07

ApplicantHdi, Inc.
Decision Date2022-11-07
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is a medical device manufactured by Hdi, Inc.. It received FDA 510(k) clearance on 2022-11-07 under approval number K222741. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Hdi, Inc.. The 510(k) number is K222741.

When was DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) approved by the FDA?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) received FDA 510(k) clearance on 2022-11-07, under approval number K222741.

What company makes DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is manufactured by Hdi, Inc..

What is the FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

The FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) is ELW.

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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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