Identity
- Trade Name
- CHIAVE x PARALLEL. OBM EUDAMEDdental attachments FDA UDI
- Generic Name
- Dental precision attachment fitting/adjustment tool FDA UDI
- Device Name
- Chiavi per parallelometro EUDAMEDIt's a metal device that serve to place the castable attachment on the master model in parallel using a parallelometer FDA UDI
- Model / Reference
- 028OCP EUDAMEDPARALLELOMETER KEY for OT BAR MULTIUSE FDA UDI
- Description
- It's a metal device that serve to place the castable attachment on the master model in parallel using a parallelometer FDA UDI
Identifiers
- Catalog Number
- 028OCP FDA UDI
- Primary DI / UDI-DI
- 08059224001517 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571CHVKX EUDAMED
- FDA Product Code
- EGI FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES 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
- 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
CHIAVE x PARALLEL. OBM 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 | 805804571CHVKX | 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 31b45411-b2d1-49a8-b689-b168a7288673 61 fields · synced Jun 17, 2026
- FDA UDI 50e40714-e129-401b-9b32-2d04690b13ca 34 fields · synced May 30, 2026