Identity
- Trade Name
- Trephine Drill 4.4/5.2mm EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Rescue instruments EUDAMEDTrephine Drill 4.4/5.2mm FDA UDI
- Model / Reference
- 37929 EUDAMEDFDA UDI
- Description
- Trephine Drill 4.4/5.2mm FDA UDI
Identifiers
- Catalog Number
- 37929 FDA UDI
- Primary DI / UDI-DI
- 07332747191165 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001487B EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Lumen/Inner Diameter — 4.400 Millimeter FDA UDIOuter Diameter — 5.200 Millimeter FDA UDI
Category: Carbide dental bur, single-use
Trephine Drill 4.4/5.2mm by Nobel Biocare AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73327470000001487B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED be03f430-a5fa-4383-9ff6-f1e5090b0d09 61 fields · synced Aug 4, 2026
- FDA UDI 53b03574-fcae-4406-99ef-ef20cb1fb4f9 37 fields · synced May 29, 2026