BruxZir Esthetic— 510(k) K213425

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K213425 for BruxZir Esthetic, Substantially Equivalent on 2021-11-17. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-10-21
Decision date: 2021-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, 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.