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Guided Screw Tap NobelParallel™ CC 5.0 11.5-13mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 38054
Identity
- Trade Name
- Guided Screw Tap NobelParallel™ CC 5.0 11.5-13mm EUDAMEDNobelParallel™ FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- Guided drills for osteotomy EUDAMEDGuided Screw Tap NobelParallel™ CC 5.0 11.5-13mm FDA UDI
- Model / Reference
- 38054 EUDAMEDFDA UDI
- Description
- Guided Screw Tap NobelParallel™ CC 5.0 11.5-13mm FDA UDI
Identifiers
- Catalog Number
- 38054 FDA UDI
- Primary DI / UDI-DI
- 07332747191448 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000014473 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- GMDN Term
- Bone tap, 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
- Outer Diameter — 5.000 Millimeter FDA UDI
Guided Screw Tap NobelParallel™ CC 5.0 11.5-13mm 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 | 733274700000014473 | 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 c2cd5998-9d68-49a7-9263-9c22765ea473 61 fields · synced Jun 19, 2026
- FDA UDI 16b3c83a-e523-4a32-88cb-8b270d9060dd 37 fields · synced May 30, 2026