Final Abutment Variobase 010.6030
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Small Diameter Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Final Abutment: Variobase EUDAMEDSC Variobase® with screw, oval, H 2mm, TAN FDA UDI
- Model / Reference
- 010.6030 EUDAMEDFinal Abutments FDA UDI
- Description
- SC Variobase® with screw, oval, H 2mm, TAN FDA UDI
Identifiers
- Catalog Number
- 010.6030 FDA UDI
- Primary DI / UDI-DI
- 07630031728616 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170097RB EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS 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
- Germany 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Height — 2 Millimeter FDA UDI
The Final Abutment Variobase (Nomenclature Code: P01020101) is a Class IIb dental implant abutment designed for use in restorative procedures. It serves as a connection interface between dental implants and prosthetic restorations, enabling secure attachment for crowns, bridges, or bars in both single-tooth and fully edentulous cases. Constructed for implant integration, it facilitates screw-retained or cemented restorative solutions, accommodating varying clinical demands.
Supplied as a single-use, non-sterile device (sterilization status: 1), the Variobase is intended for surgical use in controlled clinical settings. It is non-reusable (REUSABLE: 0) and requires proper handling per manufacturer guidelines. The device adheres to FDA 510(k) and MDR regulatory standards, with a UDI (0763003170097RB) for traceability. Sizes and configurations, such as the Ø 5.5mm × H 3.5mm variant referenced in external documentation, are standardized for compatibility with Straumann’s implant system.
Frequently asked questions
What types of dental restorations can the Final Abutment Variobase be used with, and how does it attach to the implant?
The Final Abutment Variobase is designed for both screw-retained and cemented restorative solutions, making it versatile for single-tooth replacements, bridges, or full-arch prosthetics in edentulous cases. It serves as the connection interface between Straumann dental implants and prosthetic restorations, ensuring a secure attachment for crowns, bridges, or bars.
Is the Variobase pre-sterilized, and what handling precautions should be taken before use?
The Variobase is supplied in a non-sterile state (sterilization status: 1), meaning it is not pre-sterilized for immediate clinical use. It must be sterilized prior to use in a controlled surgical setting, following the manufacturer’s guidelines to ensure proper handling and safety.
Can the Variobase be reused, or is it intended for single-use only?
The Variobase is explicitly designed for single-use only (REUSABLE: 0). It is non-reusable, and reuse is not permitted to maintain clinical safety and sterility standards.
What regulatory pathways does the Variobase follow, and how can its compliance be verified?
The Variobase complies with both FDA 510(k) and MDR (Medical Device Regulation) standards, ensuring its adherence to stringent regulatory requirements. Compliance can be verified through its UDI (0763003170097RB), which supports traceability and traceback for quality assurance.
Are there specific size configurations available for the Variobase, and how do they relate to Straumann’s implant system?
The Variobase comes in standardized sizes and configurations, such as the Ø 5.5mm × H 3.5mm variant, designed for compatibility with Straumann’s implant system. These dimensions ensure proper integration and functionality within the intended restorative workflow.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Straumann® Variobase®, PDF Straumann® Variobase® and Variobase® XC, Straumann Variobase Abutment for Bars/Bridges Final… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170354 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K170356 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0763003170097RB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (3)
- EUDAMED 7dd55b1d-9e90-4563-b4c0-5b11b21e2ef6 61 fields · synced Sep 19, 2026
- FDA UDI e86d2491-03c6-4168-b053-82ac370a36a4 36 fields · synced May 30, 2026
- FDA 510(k) K170354 1 fields · synced May 18, 2026