(31 days)
K 980613
Not Found
No
The device description details an electroforming process for fabricating dental prosthetics, which is a chemical and electrical process, not involving AI or ML. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No.
The device is used to fabricate dental tooth replacements (e.g., crowns, inlays) via an electroforming process, fitting within the definition of a dental prosthetic manufacturing system rather than a device intended for direct therapeutic use on a patient.
No
Explanation: This device is used for the fabrication of dental prosthetics (crowns, inlays, etc.) through an electroforming process. It is a manufacturing tool rather than a diagnostic tool used to identify diseases or conditions.
No
The device description clearly outlines a physical electroforming process involving an electroplating tank, electrolyte, electric current, and the deposition of gold onto a physical die. This is a hardware-based manufacturing process, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental tooth replacements (crowns, inlays, bridges, etc.). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The description details an electroforming process to create gold frameworks for dental prosthetics. It describes the materials and the technical process of creating the physical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
The Helioform System is a manufacturing system used by dental professionals to create dental prosthetics, which are considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
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
Product codes
EJT
Device Description
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. All porcelains which are used together with ceramic alloys with coefficient of thermal expansion between 13.8 and 17.2 um/m·K can be fired on galvanoformed Helioform items.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental office and dental laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Numerous in-vitro studies were conducted that looked at fit, marginal leakage, adhesion of bonding materials, stability and fracture resistance as well as on the metal/ceramic interface. What is particularly interesting in this respect is that the marginal fit of Helioform crowns is evaluated as better than those of full ceramic or titanium crowns. Studies of the fracture resistance, too, have shown better results of Helioform crowns than for base metals - including titanium.
Clinical studies have proved that crown and bridge prosthodontics with or without implants fabricated with the galvanoforming process has enormous advantages over other technologies. The thin gold jacket leaves more space for the ceramic layer which permits a more conservative preparation and thus protects the dental pulp better than an all ceramic or conventional metal ceramic restoration.
The Helioform System is as safe and as effective as the legally marketed Progold Electrocoping System. An advantage of Helioform precipitations is higher fineness of gold (99,99%) which yields to a better biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 980613
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
$\mathcal{K}$ 990670
Image /page/0/Picture/2 description: The image shows the logo for C. Hafner. The logo consists of the text "C. HAFNER" in a bold, sans-serif font, with a stylized symbol to the right. Below the name is the text "GOLD- UND SILBERSCHEIDEANSTALT" in a smaller, sans-serif font, set against a black background.
510 (k) Summary
- (a) (1) C. HAFNER GmbH & Co Bleichstraße 13-17 D-75173 Pforzheim
| Telephone: | 07231/920-210 |
|---|---|
| Fax: | 07231/920-207 |
Contact person Dr. Helmut Knosp
1999-01-29 Date:
-
Name of device: Helioform (a) (2) consisting of HF-Goldkonzentrat HF-Elektrolyt Electrolytic gold
Classification name: gold based alloy -
Legally marketed equivalent device: (a) (3) Progold Electrocoping System 510 (k) number: K 980613
-
The Helioform System is used to fabricate i. e. inlays, onlays and (a) (4) 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.
1
Image /page/1/Picture/0 description: The image shows the logo for C. Hafner Gold- und Silberscheideanstalt. The logo consists of the company name in bold, sans-serif font, with the words "GOLD- UND SILBERSCHEIDEANSTALT" in a black rectangle below the name. To the right of the name is a stylized graphic of a crucible or other metallurgical vessel.
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. All porcelains which are used together with ceramic alloys with coefficient of thermal expansion between 13.8 and 17.2 um/m·K can be fired on galvanoformed Helioform items. Physical properties of galvanoformed Helioform gold are:
| Density: | 19,3 g/cm³ |
|---|---|
| Melting point: | 1064 °C |
| Vickers Hardness after galvanoforming: | 100 HF |
| Vickers Hardness after firing on porcelain: | 25 HV |
| Grain size after galvanoforming: |