DB-CMF— 510(k) K182742

Substantially Equivalent

Dimensional Bioceramics, LLC

FDA 510(k) clearance K182742 for DB-CMF, Substantially Equivalent on 2019-06-20. Applicant: Dimensional Bioceramics, LLC. Device class: 2.

Clearance details

Applicant: Dimensional Bioceramics, LLC
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2018-09-28
Decision date: 2019-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Cruz, CA, 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.