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Guided Dense Bone Screw Tap NobelActive® WP 5.5 7-8.5 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 38182
Identity
- Trade Name
- Guided Dense Bone Screw Tap NobelActive® WP 5.5 7-8.5 mm EUDAMEDNobelActive® FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- Guided drills for osteotomy EUDAMEDGuided Dense Bone Screw Tap NobelActive® WP 5.5 7-8.5 mm FDA UDI
- Model / Reference
- 38182 EUDAMEDFDA UDI
- Description
- Guided Dense Bone Screw Tap NobelActive® WP 5.5 7-8.5 mm FDA UDI
Identifiers
- Catalog Number
- 38182 FDA UDI
- Primary DI / UDI-DI
- 07332747191561 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 — 5.500 Millimeter FDA UDI
Category: Carbide dental bur, single-use
Guided Dense Bone Screw Tap NobelActive® WP 5.5 7-8.5 mm by Nobel Biocare AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 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 7dae3d09-30dd-4962-969a-ac399440d4c0 61 fields · synced Jul 23, 2026
- FDA UDI eaf1595b-04c5-4782-901a-049492bcbac1 37 fields · synced May 30, 2026