Black Diamond— 510(k) K222323

Substantially Equivalent

Elevate Oral Care, LLC

FDA 510(k) clearance K222323 for Black Diamond, Substantially Equivalent on 2023-06-23. Applicant: Elevate Oral Care, LLC. Device class: 2.

Clearance details

Applicant: Elevate Oral Care, LLC
Product code: Code PHR
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2022-08-02
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Palm Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.