Skip to content

BruxZir 70-1138-BSA0890

by Prismatik Dentalcraft, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD745701138BSA08901 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2897-2016 FDA Class II initiated 15 Aug 2016

    Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BruxZir
Generic Name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
70-1138-BSA0890
Primary DI / UDI-DI
D745701138BSA08901
510(k) Number
FDA Product Code
EIH
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class II
Regulation Number
872.6660
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K130924)

Show all (12)

Other devices from Prismatik Dentalcraft, Inc.

See all devices from Prismatik Dentalcraft, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No