Ot Equator-Ot Bridge
FDA UDIEUDAMEDClass I (US FDA UDI)
by Rhein 83 Srl
Identity
- Trade Name
- HOLDER x CHIAVE EQUATOR EUDAMEDOT EQUATOR-OT BRIDGE FDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDI
- Device Name
- COMPONENTI PER PROTESI FISSA-steli per manipolo EUDAMED
- Model / Reference
- 774HC EUDAMEDOT EQUATOR HOLDER FDA UDI
Identifiers
- Catalog Number
- 774HC FDA UDI
- Primary DI / UDI-DI
- 08059224076980 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571CHAJM EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant holding endpiece, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant holding endpiece, reusable
Ot Equator-Ot Bridge by Rhein 83 Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rhein 83 Srl
Sources (2)
- FDA UDI ec73a1ec-7a7b-4c80-942d-ecb1afb2d3aa 33 fields · synced Aug 2, 2026
- EUDAMED 442b069b-439f-4951-80ac-5dc1030205e4 61 fields · synced Aug 2, 2026