(31 days)
Indicated for fixed and removable dental tooth replacement as follows:
Crowns Inlays, Onlays, Overlays, Partial Crowns Telescopes, Cones, Overdentures Direct Technique Double Crown Systems Implant Suprastructures Bridge Structures Baseplates
Detailed descriptions of the above indications can be found in the instructions for Use under 5.1 to 5.7
The Helioform System is used to fabricate i. e. inlays, onlays and crowns by a electroforming process. Electroformed gold framework that can be fitted with ceramic facings are an ideal combination of function, esthetic appeal and biocompatibility. The galvano-forming procedure of the Helioform System is as follows:
An electroconductive polyurethane duplicate die is used as a cathode in an electroplating tank. The electrolyte in this tank contains fine gold in solution (HF-Elektrolyt).
When the electric current between the anode and cathode is activated, positively charged gold ions will travel from the electrolyte to the cathode, where they are deposited and form a gold plating.
Galvanoformed parts are produced in Helioform technique using polyurethane dies. The dies are coated with a conductive silver spacer and serves as the cathode of the electroplating circuit.
The electrolyte consists of a non-cyanide gold sulfite solution to which non-cyanide gold concentrate (HF-Goldkonzentrat) is continuously released to replace the gold precipitated on the cathode.
When the electric current is turned on, gold will be deposited on the polyurethane die. The thickness of the laver depends on the duration of the live cycle (approximately 20 um per hour). It can be selected between 200 - 400 um.
The galvanoformed item contains only fine gold with a fineness of 99,99 %. The amount of material required is only about 60 % of what a comparable casting alloy with high gold content would require.
This document is a 510(k) premarket notification for the Helioform dental device. The primary goal of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This submission focuses on comparing the physical properties and clinical applications of the Helioform System to the predicate Progold Electrocoping System.
Here's an analysis of the provided text regarding acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in the typical sense of numerical thresholds for a new device to meet. Instead, it relies on demonstrating that the Helioform System possesses comparable or superior physical properties and clinical effectiveness to its predicate device, the Progold Electrocoping System. The "performance" often refers to physical properties of the fine gold and general clinical outcomes.
| Feature / Property | Predicate Device (Progold) Performance (where specified) | Helioform Performance | Comparison/Acceptance (Implied) |
|---|---|---|---|
| Material | 99.96% electroformed fine gold | 99.99% electroformed fine gold | Superior fineness: Helioform has higher fineness (99.99%) compared to Progold (99.96%), which is highlighted as an advantage for biocompatibility. This implicitly surpasses the predicate's performance in this aspect. |
| Dies used | Stone dies | Polyurethane dies | Difference noted: Helioform uses polyurethane dies, while Progold uses stone dies. The impact on performance is discussed in terms of bond strength and compatibility with porcelains. Both are stated to have "excellent bond strength." |
| Bond strength to porcelains | Excellent bond strength to conventional porcelains | Excellent bond strength and compatibility to conventional porcelains as well as to low firing porcelains with high coefficient of thermal expansion | Comparable/Extended: Helioform claims "excellent bond strength and compatibility" comparable to Progold's "excellent bond strength" with an added benefit of compatibility with "low firing porcelains with high coefficient of thermal expansion," suggesting an extended range of use without compromising bond strength. |
| Production Speed/Capacity | 16 gold copings in 6-7 hours | 10-20 gold copings in 10 hours | Comparable/Slower per coping: Progold produces approximately 2.3-2.6 copings per hour, while Helioform produces 1-2 copings per hour. However, Helioform produces a similar batch size (10-20 vs 16) but over a longer duration. This is presented as a difference, not necessarily an inferior performance that would hinder acceptance in a 510(k) context given other benefits. |
| Gold Electrolyte content | 15 g/l gold content | 10 g/l gold content | Difference noted: This is a difference in formulation and process, not directly a performance criterion for the final product in this context. |
| Concentrate gold content | Not specified | 100 g gold content | Difference noted: Similar to electrolyte content, a process difference. |
| Recovery capabilities | Recovery capabilities of precious metals from solution | Recovery recommendations of fine gold from Electrolyte | Similar functionality: Both systems address precious metal recovery, indicating a comparable aspect of responsible manufacturing, even if the details of the "recommendations" versus "capabilities" differ slightly in phrasing. |
| Die Divesting/Separation | Stone divesting capability | Thermal separation of polyurethane dies | Difference in method: Both systems have a method for separating the die, suited to their respective die materials. This is a functional difference in the manufacturing process, not a final device performance. |
| Density (final product) | N/A | 19.3 g/cm³ | Reported property: This is a specific physical property of the Helioform fine gold, which is generally consistent with pure gold. There's no specific acceptance criterion against a predicate value given. |
| Melting point | N/A | 1064 °C | Reported property: This melting point is characteristic of pure gold. There's no specific acceptance criterion. |
| Vickers Hardness (after galvanoforming) | N/A | 100 HV | Reported property: A measure of the material's hardness. No specific acceptance criterion provided. |
| Vickers Hardness (after firing on porcelain) | N/A | 25 HV | Reported property: Hardness after processing, indicating its workability and durability. No specific acceptance criterion provided. |
| Grain size (after galvanoforming) | N/A |
§ 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.