Identity
- Trade Name
- NobelReplace® FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Drill Tapered WP 5x11.5 mm Single-Patient Use FDA UDI
- Model / Reference
- 37086 FDA UDI
- Description
- Drill Tapered WP 5x11.5 mm Single-Patient Use FDA UDI
Identifiers
- Catalog Number
- 37086 FDA UDI
- Primary DI / UDI-DI
- 07332747065572 FDA UDI
- FDA Product Code
- NDP 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
Yes
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
- Outer Diameter — 5.000 Millimeter FDA UDILength — 11.500 Millimeter FDA UDI
Category: Fixture/appliance dental drill bit, single-use
NobelReplace® 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 45efbd62-7e0b-4502-a47b-afd6268e5caf 37 fields · synced May 30, 2026