Identity
- Trade Name
- CAPPETTA EQUATOR NERA da lab. 50u. EUDAMEDDENTAL EQUIPMENTS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Posizionatori EUDAMEDDISPOSABLE device in plastic material to be embodied in a removable prosthesis FDA UDI
- Model / Reference
- CN068-50 EUDAMEDCAPPETTA EQUATOR NERA da lab. 50u. FDA UDI
- Description
- DISPOSABLE device in plastic material to be embodied in a removable prosthesis FDA UDI
Identifiers
- Catalog Number
- CN068-50 FDA UDI
- Primary DI / UDI-DI
- 08059224128078 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571PSZP9 EUDAMED
- FDA Product Code
- EGG FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CAPPETTA EQUATOR NERA da lab. 50u. by Rhein 83 S.r.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 | 805804571PSZP9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rhein 83 S.r.l.
- EUDAMED SRN
- IT-MF-000005998
Sources (2)
- EUDAMED 62a7f94d-33bd-4de8-a171-e415397fcd6a 61 fields · synced Jun 19, 2026
- FDA UDI 33710bb9-c9b9-4d6e-bceb-5a1d867a7610 34 fields · synced May 30, 2026