Ot Equator - Ot Bridge
FDA UDIEUDAMEDClass I (US FDA UDI)
by Rhein 83 Srl
Identity
- Trade Name
- MONC. di TRASF. x IMPRONTA EQUATORpz.100 EUDAMEDOT EQUATOR - OT BRIDGE FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Componenti per protesi fissa EUDAMEDStraight Titanium abutment H 3mm with passing holes, for temporary screwed prosthesis, with Titanium screw H 2 mm, white Seegers with handle and one Pink Seeger with handle FDA UDI
- Model / Reference
- MTE-100 EUDAMEDIMPRESSION COPINGS 100 U. FDA UDI
- Description
- Straight Titanium abutment H 3mm with passing holes, for temporary screwed prosthesis, with Titanium screw H 2 mm, white Seegers with handle and one Pink Seeger with handle FDA UDI
Identifiers
- Catalog Number
- MTE-100 FDA UDI
- Primary DI / UDI-DI
- 08059224139869 EUDAMEDFDA UDI
- Basic UDI-DI
- 805804571TRPP6 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
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 suprastructure, permanent, preformed
Ot Equator - Ot Bridge by Rhein 83 Srl — Class I — 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
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- 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 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 36435d65-1bed-449a-be1e-f6d87e0ae7b7 34 fields · synced Jul 9, 2026
- EUDAMED f75a7d56-8e34-4712-b32d-7e8d59e0c280 61 fields · synced Jul 9, 2026