Identity
- Trade Name
- SPHERO BLOCK NORMO FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- 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
- Model / Reference
- S/BLOCK NORMO BRANEMARK ø 3,3 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
- 002BRK334R FDA UDI
- Primary DI / UDI-DI
- D821002BRK334R0 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Sphero Block Normo by Rhein 83 Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rhein 83 Srl
Sources (1)
- FDA UDI 0e0b358e-098c-43a7-bbe4-6a204c476a6d 35 fields · synced Jun 1, 2026