Identity
- Trade Name
- OT BOX MONO NORMO pz.2 EUDAMEDDENTAL ATTACHMENTS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Calcinabili EUDAMEDSINGLE USE castable device Housing for retentive caps FDA UDI
- Model / Reference
- 042AMN EUDAMEDMONO OT BOX STANDARD size pz.2 FDA UDI
- Description
- SINGLE USE castable device Housing for retentive caps FDA UDI
Identifiers
- Catalog Number
- 042AMN FDA UDI
- Primary DI / UDI-DI
- 08059224001265 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571CLCK5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
OT BOX MONO NORMO pz.2 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 | 805804571CLCK5 | 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 6b659b33-0e08-4fcc-849f-5743687525c2 61 fields · synced Jul 22, 2026
- FDA UDI eb9cc004-b86b-4318-a924-1fb6434d6a87 34 fields · synced May 30, 2026