Identity
- Trade Name
- BruxZir FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- BruxZir Shaded-16 CAD/CAM 40x19 A3 5-Pack FDA UDI
- Model / Reference
- 4400186 FDA UDI
- Description
- BruxZir Shaded-16 CAD/CAM 40x19 A3 5-Pack FDA UDI
Identifiers
- Catalog Number
- 4400186 FDA UDI
- Primary DI / UDI-DI
- D74544001861 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
Yes
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
Dimensions & Sizes
- Size
- Height — 40 Millimeter FDA UDI
Category: Dental appliance fabrication material, ceramic
BruxZir by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI ef809190-f233-4d33-ba69-7a2db284f06d 37 fields · synced May 30, 2026