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510(k) K252446

BruxZir® NOW by Prismatik Dentalcraft, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2025
Date Received
August 4, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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Other clearances for product code EIH

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  • K250826 — Multi M Series (June 12, 2025)
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  • K250673 — CERABIEN MiLai (May 29, 2025)
  • K250534 — Biomic Color Opaque (May 20, 2025)