Identity
- Trade Name
- Instrument Set FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Convenience kit of Bioclear products used in dental restorations. FDA UDI
- Model / Reference
- Elite FDA UDI
- Description
- Convenience kit of Bioclear products used in dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9498000112 FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual non-rotary dental instrument handle
Instrument Set 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 d94429a7-dae7-4631-9992-aaa0a58cf6f5 33 fields · synced Jun 1, 2026