BruxZir® Shaded 16 PLUS— 510(k) K254283

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K254283 for BruxZir® Shaded 16 PLUS, Substantially Equivalent on 2026-01-30. Applicant: Prismatik Dentalcraft, Inc..

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code EIH
Advisory panel: Dental
Date received: 2025-12-31
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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