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Activating tool
EUDAMEDFDA UDIClass I (EU MDR)
Ref A 1 Model A 1
by Alphadent NV
Identity
- Trade Name
- Activating tool EUDAMEDCEKA & PRECI-LINE ATTACHMENTS FDA UDI
- Generic Name
- Dental precision attachment fitting/adjustment tool FDA UDI
- Device Name
- ACTIVATING TOOL EUDAMEDACTIVATING TOOL 1 P. FDA UDI
- Model / Reference
- A 1 EUDAMEDFDA UDI
- Description
- ACTIVATING TOOL 1 P. FDA UDI
Identifiers
- Catalog Number
- A 1 FDA UDI
- Primary DI / UDI-DI
- 04260576941701 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260576941701 EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental precision attachment fitting/adjustment tool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Activating tool by Alphadent NV — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260576941701 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alphadent NV
- EUDAMED SRN
- BE-MF-000000923
Sources (2)
- EUDAMED c6ecb67d-8dd9-4531-9c6f-2784d6cff885 61 fields · synced Jul 10, 2026
- FDA UDI dcf2130f-01ed-4439-b008-b9a63a8c2d95 35 fields · synced May 30, 2026