Identity
- Trade Name
- SPHERO FLEX FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc. FDA UDI
- Model / Reference
- SPHERO FLEX STERI OSS ø 3.8 h.5 RIV.TiN FDA UDI
- Description
- DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc. FDA UDI
Identifiers
- Catalog Number
- 109STO5R FDA UDI
- Primary DI / UDI-DI
- 08059224049038 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
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
Category: Dental implant suprastructure, permanent, preformed
Sphero Flex by Rhein 83 Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rhein 83 Srl
Sources (1)
- FDA UDI d146895b-fffc-472a-9fae-1fede4246148 34 fields · synced Jun 8, 2026