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Ot Equator Titanium Abutment
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K142211
by Rhein 83 Srl
Identity
- Trade Name
- OT EQUATOR TITANIUM ABUTMENT FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. FDA UDI
- Model / Reference
- BRANEMARK NP H 4 FDA UDI
- Description
- The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. FDA UDI
Identifiers
- Catalog Number
- 030BRK334 FDA UDI
- Primary DI / UDI-DI
- 08059224071787 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
MR Unsafe FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Ot Equator Titanium Abutment by Rhein 83 Srl — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — 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 (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142211 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171409 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160382 | Class II | Active |
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Manufacturer
- Manufacturer
- Rhein 83 Srl
- FDA Applicant
- Rhein'83 Srl
Sources (2)
- FDA UDI 3b64abcb-453b-42ed-ac27-6b4811fd9d67 58 fields · synced Jun 18, 2026
- FDA 510(k) K142211 1 fields · synced May 22, 2026