FDA 510(k)

Black Diamond

K-Number: K222323 · 2023-06-23

Decision Date2023-06-23

Product CodePHR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Black Diamond is the device name listed in this FDA 510(k) record. The listed applicant is Elevate Oral Care, LLC. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K222323. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Black Diamond?

Black Diamond is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Elevate Oral Care, LLC. The 510(k) number is K222323.

When did Black Diamond receive FDA 510(k) clearance?

Black Diamond received FDA 510(k) clearance on 2023-06-23, under 510(k) number K222323.

Who is the listed applicant for Black Diamond?

The FDA 510(k) record lists Elevate Oral Care, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Black Diamond?

The FDA product code for Black Diamond is PHR.

Other records listing Elevate Oral Care, LLC as applicant

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.