Identity
- Trade Name
- Nobel Biocare N1™ FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- OsseoShaper 2 Nobel Biocare N1™ 3.5x11mm FDA UDI
- Model / Reference
- 300893 FDA UDI
- Description
- OsseoShaper 2 Nobel Biocare N1™ 3.5x11mm FDA UDI
Identifiers
- Catalog Number
- 300893 FDA UDI
- Primary DI / UDI-DI
- 07332747162059 FDA UDI
- FDA Product Code
- QRQ FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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 — 11.000 Millimeter FDA UDIOuter Diameter — 3.500 Millimeter FDA UDI
Category: Fixture/appliance dental drill bit, single-use
Nobel Biocare N1™ by Nobel Biocare AG — Class I — 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AG
Sources (1)
- FDA UDI 90174333-978f-4a8d-8baf-80f944304abd 37 fields · synced Jun 8, 2026