Identity
- Trade Name
- BruxZir Shaded 16 PLUS FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- BruxZir Shaded 16 PLUS Milling Blank A1 20mm Z FDA UDI
- Model / Reference
- 70-1185-BXP0050 FDA UDI
- Description
- BruxZir Shaded 16 PLUS Milling Blank A1 20mm Z FDA UDI
Identifiers
- Catalog Number
- 70-1185-BXP0050 FDA UDI
- Primary DI / UDI-DI
- D745701185BXP00500 FDA UDI
- 510(k) Number
- K130924 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, ceramic
A comprehensive medical device directory listing the BruxZir Shaded 16 PLUS Milling Blank A1 20mm Z dental material.
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Cleared under the same submission
K130924 also covers:
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- ZIRento — DISTRIBUDENT, LLC
- BruxZir — PRISMATIK DENTALCRAFT, INC.
- BruxZir — PRISMATIK DENTALCRAFT, INC.
- BruxZir — PRISMATIK DENTALCRAFT, INC.
- BruxZir — PRISMATIK DENTALCRAFT, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI b2d6837e-a223-4033-87c7-da55e3e3f0ca 36 fields · synced Jul 22, 2026