Identity
- Trade Name
- CHIAVE ESAGONALE x SPHERO FLEX/BLOCK EUDAMEDSPHERO FLEX FDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDI
- Device Name
- CRICCHETTO DINAMOMETRICO E CHIAVI EUDAMEDSTERILIZABLE Devices. Screwdriver with hex connection for Sphero Line family products. FDA UDI
- Model / Reference
- 771CEF EUDAMEDKEY FOR SPHERO FLEX/BLOCK FDA UDI
- Description
- STERILIZABLE Devices. Screwdriver with hex connection for Sphero Line family products. FDA UDI
Identifiers
- Catalog Number
- 771CEF FDA UDI
- Primary DI / UDI-DI
- 08059224002255 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571CRCKP EUDAMED
- FDA Product Code
- ELR FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant holding endpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3810 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 ESAGONALE x SPHERO FLEX/BLOCK 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 | 805804571CRCKP | 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 75f917b6-ed90-412a-9441-f89191bf9131 61 fields · synced Jun 18, 2026
- FDA UDI 857146cb-13b7-4b3f-b164-e8762b2b1041 34 fields · synced May 30, 2026