BruxZir® Shaded 16 PLUS— 510(k) K254283
Substantially EquivalentPrismatik Dentalcraft, Inc.
FDA 510(k) clearance K254283 for BruxZir® Shaded 16 PLUS, Substantially Equivalent on 2026-01-30. 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
- Decision date
- 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.