Sphero Block Normo
FDA UDIEUDAMEDClass II (US FDA UDI)
by Rhein 83 Srl
Identity
- Trade Name
- S.BLOCK N. Tri Nex ø 3,5 h.4 TiN EUDAMEDSPHERO BLOCK NORMO FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- ATTACCHI DIRETTI IN TITANIO EUDAMEDTitanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla. FDA UDI
- Model / Reference
- 002TN354R EUDAMEDS/BLOCK NORMO Tri Nex ø 3,5 h.4 TiN FDA UDI
- Description
- Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla. FDA UDI
Identifiers
- Catalog Number
- 002TN354R FDA UDI
- Primary DI / UDI-DI
- 08059224139715 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571ADTK5 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Sphero Block Normo by Rhein 83 Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rhein 83 Srl
Sources (2)
- FDA UDI a2dfc652-143a-4772-935f-2f67f1df55d2 34 fields · synced Sep 17, 2026
- EUDAMED 66908c79-0e50-4ccd-8a5c-ae6d1686560a 61 fields · synced Sep 17, 2026