Identity
- Trade Name
- Black Triangle Kit FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Convenience kit of Bioclear products used in anterior dental restorations. FDA UDI
- Model / Reference
- Starter FDA UDI
- Description
- Convenience kit of Bioclear products used in anterior dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9498010032 FDA UDI
- GMDN Term
- Dental implantation depth/angle gauge, reusable FDA UDI
Classification
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental implantation depth/angle gauge, reusableDental matrix band kitDental abrasive strip, reusable
Black Triangle Kit by Bioclear Matrix Systems, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bioclear Matrix Systems, LLC
Sources (1)
- FDA UDI b1764b8f-a88b-4736-af2f-eeaa3c670552 33 fields · synced Jun 8, 2026