BruxZir® NOW— 510(k) K252446

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K252446 for BruxZir® NOW, Substantially Equivalent on 2025-09-03. Applicant: Prismatik Dentalcraft, Inc..

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EIH
Advisory panel: Dental
Date received: 2025-08-04
Decision date: 2025-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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