(52 days)
Porta PressOver is a gold-silver-palladium alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/Onlays, - Crowns, - Short span bridges and can be used for - Telescopic and milling work. Porta PressOver can be utilized as a conventional casting alloy, in which it can be veneered with dental composites, as well as a ceramic alloy, which has to be veneered (pressed over) by the IMAGINE h.e. Press ceramic of Wieland Dental + Technik GmbH & Co. KG.
Porta PressOver is a gold-silver-palladium alloy (type 3) with high contents of noble metals (76,5%) intended for dental technicians to fabricate dental restorations. It has an indication for use, which ranges from inlays/onlays and single crowns up to short span bridges with two pontics. In addition, it can be used for telescopic and milling work. Porta PressOver can be utilized as a conventional casting alloy as well as a ceramic alloy, which has to be veneered by the Pressover-Technique with IMAGINE® h.e. Press Ceramic. Porta PressOver is highly corrosion resistant and has an excellent biocompatibility. It meets all relevant essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided document is a 510(k) Pre-market Notification for a dental alloy named "Porta PressOver." This type of submission is for medical devices, but it does not involve an AI/ML algorithm or software as a medical device (SaMD).
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this device.
The document describes a physical material (a gold-silver-palladium alloy) intended for fabricating dental restorations. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, typically through material composition, mechanical properties, biocompatibility, and intended use, rather than performance metrics related to an algorithm's diagnostic or predictive capabilities.
Summary of relevant information from the document:
- Device Name: Porta PressOver
- Device Type: Gold-silver-palladium alloy
- Intended Use: For dental technicians to fabricate dental restorations such as inlays/onlays, crowns, short span bridges, and for telescopic and milling work. It can be used as a conventional casting alloy (veneered with dental composites) or a ceramic alloy (veneered with IMAGINE h.e. Press Ceramic).
- Predicate Device: Pontor 4CF (K911541)
- Basis for Clearance: Substantial equivalence to the predicate device. The document states it "meets all relevant essential requirements of the European directive 93/42/ECC concerning medical devices" and is highly corrosion resistant with excellent biocompatibility, implying these characteristics were compared to the predicate.
§ 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.