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510(k) Data Aggregation
(90 days)
Straumann BLX Variobase Abutment
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
BLX Variobase abutments are two-piece abutments composed of the following components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping or crown), Basal Screw. The BLX Variobase abutments are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center. The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw. The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw. The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment). The BLX Variobase abutments are cleared under K173961. The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).
Here's a breakdown of the acceptance criteria and the study information for the Straumann® BLX Variobase Abutment, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sterilization Process | Validation according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17655-1. | Sterilization process for BLX Variobase Abutments was validated according to applicable recommendations in FDA guidance and ISO 17655-1. |
| Biocompatibility | Evaluation according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1". No new issues of biocompatibility raised. | Biocompatibility was evaluated according to ISO 10993-1:2009 and FDA Guidance. No new issues of biocompatibility were raised, and therefore, no additional biocompatibility testing was required. |
| Dynamic Fatigue (Implant-Abutment System) | Dynamic loading test for endosseous dental implants according to FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. Performance equivalent to predicate and reference devices. | Test results demonstrated the Straumann® BLX Implant/Variobase final abutment system is equivalent to the predicate and reference devices. Test environment: 0.9% NaCl at 37°C. |
| Substantial Equivalence | Demonstration of substantial equivalence to primary predicate and reference devices. | The documentation demonstrated the BLX Variobase Abutments are substantially equivalent to the primary predicate and reference devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state sample sizes for specific 'test sets' in the way one might expect for a clinical trial or AI model evaluation. However, for the bench testing:
- Dynamic Fatigue Test: The text implies a sufficient number of samples were tested to demonstrate equivalence according to ISO 14801 and the FDA guidance. No specific number is given.
- Data Provenance: The studies were conducted as part of the device manufacturer's (Institut Straumann AG) regulatory submission to the FDA, suggesting a controlled internal testing environment. The country of origin for the data is implied to be related to the manufacturer's R&D facilities. This is a prospective set of tests conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. The Straumann® BLX Variobase Abutment is a medical device, and its acceptance criteria are based on engineering performance specifications, material science, and regulatory compliance (e.g., sterilization efficacy, biocompatibility, mechanical strength), not on interpretation of images or patient data by experts. Therefore, "ground truth" in the clinical sense (e.g., diagnosis by radiologists) is not relevant here.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves bench testing and adherence to standards, not human adjudication of a clinical outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an endosseous dental implant abutment, which is a prosthetic component.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. This device is a physical medical component, not an algorithm. Bench tests evaluate the standalone performance of the physical device under simulated conditions.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is established through:
- Established Standards: Adherence to international standards like ISO 14801 (dynamic loading) and ISO 10993-1 (biocompatibility), and ISO 17655-1 (sterilization).
- Regulatory Guidance: Compliance with specific FDA guidance documents for root-form endosseous dental implants and abutments.
- Material Specifications: Properties of the materials used (Ti-6Al-7Nb) meet established strength and biocompatibility profiles.
- Functional Equivalence: Demonstration that the new device performs equivalently to previously cleared predicate devices under defined test conditions.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device. It is a physical product, not an AI model requiring data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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