Ot Equator Titanium Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
by Rhein 83 Srl
Identity
- Trade Name
- OT EQUATOR CERTAIN ø 4,1 h.6 EUDAMEDOT EQUATOR TITANIUM ABUTMENT 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
- 130IIC46 EUDAMEDOT EQUATOR CERTAIN ø 4,1 h.6 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
- 130IIC46 FDA UDI
- Primary DI / UDI-DI
- 08059224089775 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
Ot Equator Titanium Abutment by Rhein 83 Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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 115c3565-5b25-4690-9aef-8130d1b40110 34 fields · synced Sep 17, 2026
- EUDAMED 225027b5-7bd8-4364-9a1f-e5aaa35f24bd 61 fields · synced Sep 17, 2026