Identity
- Trade Name
- BruxZir FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- BruxZir™ White Polishing Cup (3-pack) FDA UDI
- Model / Reference
- 70-1014-BRX0012 FDA UDI
- Description
- BruxZir™ White Polishing Cup (3-pack) FDA UDI
Identifiers
- Catalog Number
- 70-1014-BRX0012 FDA UDI
- Primary DI / UDI-DI
- D745701014BRX00121 FDA UDI
- FDA Product Code
- EHJ FDA UDI
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
Yes
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 abrasive point, reusable
BruxZir by Prismatik Dentalcraft, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental abrasive point, reusable.
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- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Strauss Diamond — Diamond Strauss Instruments Inc · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI c9aabea3-ff9f-4600-bd05-1cd07de69eb1 35 fields · synced May 31, 2026