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FDA 510(k)

RODIN Palette Naturalizing Kit

K-Number: K223365 · 2023-03-27

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2023-03-27
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RODIN Palette Naturalizing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223365. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RODIN Palette Naturalizing Kit?

RODIN Palette Naturalizing Kit is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K223365.

When did RODIN Palette Naturalizing Kit receive FDA 510(k) clearance?

RODIN Palette Naturalizing Kit received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223365.

Who is the listed applicant for RODIN Palette Naturalizing Kit?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Palette Naturalizing Kit?

The FDA product code for RODIN Palette Naturalizing Kit is EBD.

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Related Devices (Code: EBD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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