(62 days)
BioPorta G is a gold-platinum alloy that can be used by dental technicians to fabricate der appliances for patients.
It is intended for manufacturing
- Inlays/ Onlays
- Partial crowns
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
and can be used for
- Telescopic and milling work
BioPorta G can be veneered with suitable dental ceramics as well as with dental-composites.
In addition BioPorta G, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of BioPorta G are joined to form dental restorations.
BioPorta G is a gold-platinum ceramic alloy with high contents of noble metals (97 %) intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires.
BioPorta G is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
BioPorta G can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
The provided documentation is a 510(k) premarket notification for a dental alloy named "BioPorta G". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement with AI.
Therefore, the requested information regarding acceptance criteria derived from a performance study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not applicable to this document.
The 510(k) summary (and accompanying FDA letter) indicates a different kind of "acceptance criteria":
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) device is demonstrating substantial equivalence to a predicate device that is already legally marketed. This is achieved by comparing the new device's indications for use, technological characteristics, and performance data (often mechanical, chemical, and biological properties for materials like dental alloys) to the predicate device.
- Compliance with Standards: The device is stated to "fully comply to the international standard ISO 9693" and "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." These standards and directives serve as "acceptance criteria" for the material properties and safety of the alloy.
Based on the provided information, I can summarize what is available regarding "acceptance" in the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device "Performance":
| Acceptance Criterion (as per 510(k) process or standards) | Reported BioPorta G "Performance" / Characteristics |
|---|---|
| Substantial Equivalence to Predicate Device | Determined by FDA to be substantially equivalent to V-Gnathos Plus (K952122). |
| Indication for Use Appropriateness | Indicated for manufacturing inlays/onlays, partial crowns, crowns, short span bridges, long span bridges, removable partials. Can be used for telescopic, milling work, and laser welding (in wire form). Can be veneered with suitable dental ceramics and composites. These indications are considered appropriate and substantially equivalent to the predicate. |
| Biocompatibility | Reported as having "excellent biocompatibility." |
| Corrosion Resistance | Reported as "highly corrosion resistant." |
| Composition | Gold-platinum ceramic alloy with high noble metal content (97%). Free of copper. |
| Compliance with ISO 9693 | "Fully complies to the international standard ISO 9693" (likely related to dental materials for metal-ceramic restorations). |
| Compliance with EU Directive 93/42/ECC | "Fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." |
| Aesthetic Properties | Golden yellow color provides "an excellent basis for manufacturing aesthetically pleasing dental restorations." |
Non-Applicable Information for this 510(k) Document:
The following points are based on typical performance studies for diagnostic devices, particularly those involving AI or image analysis. This 510(k) is for a material, a dental alloy. Therefore, these requested details are not present in this submission.
- 2. Sample size used for the test set and the data provenance: Not applicable. Performance data would relate to material properties, not a dataset in the typical sense of diagnostic algorithms.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a material would involve laboratory testing and chemical analysis, not expert consensus on images.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a material, not a diagnostic or AI-assisted device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For a material, ground truth is typically established through standardized physical, chemical, and biological testing methods (e.g., tensile strength, corrosion tests, biocompatibility assays per ISO standards), not expert consensus, pathology, or outcomes data in the diagnostic context. The document mentions compliance with ISO 9693, implying such testing was performed.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.