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Cutting guide Engaging Wide H 3.5
EUDAMEDFDA UDIClass I (EU MDR)
Ref IPD/KA-IW-35Model AINC3D
Identity
- Trade Name
- Cutting guide Engaging Wide H 3.5 EUDAMEDIPD FDA UDI
- Generic Name
- Dental implant suprastructure reamer guide FDA UDI
- Device Name
- Cutting guide EUDAMEDCutting guide Engaging Wide H 3.5 FDA UDI
- Model / Reference
- AINC3D EUDAMEDFDA UDIIPD/KA-IW-35 EUDAMED
- Description
- Cutting guide Engaging Wide H 3.5 FDA UDI
Identifiers
- Catalog Number
- IPD/KA-IW-35 FDA UDI
- Primary DI / UDI-DI
- 08435566616808 EUDAMEDFDA UDI
- Basic UDI-DI
- 8435566621BS EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280,Q010299 EUDAMED
- GMDN Term
- Dental implant suprastructure reamer guide FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cutting guide Engaging Wide H 3.5 by Implant Protesis Dental 2004 S.l. — Class I — 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 | 8435566621BS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Implant Protesis Dental 2004 S.l.
- EUDAMED SRN
- ES-MF-000002195
Sources (2)
- EUDAMED 72d51f66-631b-464b-be86-15dd1a30a0ce 61 fields · synced Jul 9, 2026
- FDA UDI 762a37b1-0468-4cf4-b10b-6c1bdd1e9c44 35 fields · synced May 30, 2026