Identity
- Trade Name
- Screw Tap NobelActive® RP 5.0 EUDAMEDNobelActive® FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Reusable drills for osteotomy EUDAMEDScrew Tap NobelActive® RP 5.0 FDA UDI
- Model / Reference
- 36238 EUDAMEDFDA UDI
- Description
- Screw Tap NobelActive® RP 5.0 FDA UDI
Identifiers
- Catalog Number
- 36238 FDA UDI
- Primary DI / UDI-DI
- 07332747025835 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001226R EUDAMED
- Direct Marketing DI
- 07332747028454 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone tap, reusable 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.000 Millimeter FDA UDI
Screw Tap NobelActive® RP 5.0 by Nobel Biocare AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 73327470000001226R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 55631518-3f1b-47ad-9285-3e49f25c7453 61 fields · synced Jul 15, 2026
- FDA UDI 9982184a-44a6-4fbb-a149-4286522b86f6 37 fields · synced May 30, 2026