K252446

Substantially Equivalent

BruxZir® NOW

Applicant: Prismatik Dentalcraft, Inc.
Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.