Identity
- Trade Name
- Nobel Biocare N1™ FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC NP 2.5mm FDA UDI
- Model / Reference
- 301058 FDA UDI
- Description
- Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC NP 2.5mm FDA UDI
Identifiers
- Catalog Number
- 301058 FDA UDI
- Primary DI / UDI-DI
- 07332747163322 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 2.500 Millimeter FDA UDI
Category: Dental prosthesis/implant abutment screw
Nobel Biocare N1™ by Nobel Biocare AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental prosthesis/implant abutment screw.
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- Implant Prosthetics — PREAT Corporation · Class II
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- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AG
Sources (1)
- FDA UDI b3ff6111-efa2-4817-9df4-926b00e4aa54 37 fields · synced May 30, 2026