Identity
- Trade Name
- BRASSELER USA FDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Device Name
- NTD11T256 NITI D11T 25MM 1P FDA UDI
- Model / Reference
- 5009753U0 FDA UDI
- Description
- NTD11T256 NITI D11T 25MM 1P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840018600065 FDA UDI
- FDA Product Code
- EKK 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
- 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
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: Manual endodontic filling material spreader
Brasseler Usa by Nordent Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic filling material spreader.
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- EZ-Fill Bi-Directional Spiral — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- SPREADERS — DiaDent Group International · Class I
- SPREADERS — DiaDent Group International · Class I
- PLUGGERS — DiaDent Group International · 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
- Nordent Manufacturing Inc
Sources (1)
- FDA UDI b9109336-cddc-419b-8a18-6f93655db2aa 33 fields · synced May 30, 2026