Identity
- Trade Name
- D11T root canal spreader FDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Model / Reference
- ST011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060723456 FDA UDI
- FDA Product Code
- EMN FDA UDI
- GMDN Term
- Manual endodontic filling material spreader FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
D11T root canal spreader by Berman Instruments LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Berman Instruments LLC
Sources (1)
- FDA UDI e9dd72f1-a168-420b-8941-4066008a0cab 33 fields · synced Jun 8, 2026