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FDA 510(k)

Black Diamond

K-Number: K222323 · 2023-06-23

ApplicantElevate Oral Care, LLC
Decision Date2023-06-23
Product CodePHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Black Diamond is a medical device manufactured by Elevate Oral Care, LLC. It received FDA 510(k) clearance on 2023-06-23 under approval 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. It is manufactured by Elevate Oral Care, LLC. The 510(k) number is K222323.

When was Black Diamond approved by the FDA?

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

What company makes Black Diamond?

Black Diamond is manufactured by Elevate Oral Care, LLC.

What is the FDA product code for Black Diamond?

The FDA product code for Black Diamond is PHR.

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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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