(58 days)
AGC Special Alloy is a gold-platinum 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 - Long span bridges - Pontics for AGC bridges - Removable partials and can be used for - . Telescopic and millinq work AGC Special Alloy can be veneered with suitable dental ceramics as well as with dentalcomposites. In addition, AGC Special Alloy, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of AGC Special alloy are joined to form dental restorations.
AGC Special Alloy is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing 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. AGC Special Alloy 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. AGC Special Alloy 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.
This document describes a 510(k) premarket notification for a dental alloy, not a device that would typically have performance metrics described by a study using human readers, ground truth, or sample sizes in the way one would describe an AI or diagnostic imaging device.
The product concerned, "AGC Special Alloy," is a gold-platinum ceramic alloy intended for dental technicians to fabricate dental restorations. The 510(k) summary focuses on its material properties, biocompatibility, and compliance with existing standards for dental alloys.
Therefore, many of the requested categories related to AI/diagnostic device performance studies (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of medical device submission.
However, I can extract information relevant to the material's performance and acceptance criteria based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Standard Met | Reported Device Performance / Compliance |
|---|---|
| Corrosion Resistance | Highly corrosion resistant |
| Biocompatibility | Excellent biocompatibility |
| Compliance to ISO 9693 (Dental casting gold alloys) | Fully complies to ISO 9693 |
| Compliance to European Directive 93/42/ECC (Medical devices) | Fulfils the essential requirements of the European directive 93/42/ECC |
| Suitable for veneering with dental ceramics | Yes, can be veneered with suitable dental ceramics |
| Suitable for veneering with dental composites | Yes, can be veneered with dental composites |
| Aesthetic basis for restorations (golden yellow color) | Provides an excellent basis for manufacturing aesthetically pleasing dental restorations |
| Suitability for telescopic and milling work | Yes, suitable for telescopic and milling work |
| Suitability for laser welding (in shape of wires) | Yes, can be used for laser welding in the shape of wires |
| Free of copper | Yes, free of copper |
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of device. The document does not describe a "test set" in the context of diagnostic performance. The evaluations are likely material characterization tests performed on samples of the alloy. The provenance of such material testing data is typically from the manufacturer's internal laboratories or certified testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would refer to established material science or metallurgical standards, not expert clinical consensus on images or diagnoses.
4. Adjudication method for the test set:
- Not applicable. Material property testing follows standardized protocols, not adjudication methods.
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 device is a dental alloy, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material, not an algorithm.
7. The type of ground truth used:
- For physical/chemical properties (e.g., corrosion resistance, biocompatibility, mechanical properties), the ground truth is established via international and national standards (e.g., ISO 9693, European Directive 93/42/ECC) and validated material testing methodologies. Biocompatibility would be based on established toxicology and material interaction protocols.
8. The sample size for the training set:
- Not applicable for this type of device. There is no "training set" in the machine learning sense for a dental alloy. Material development and refinement involve iterative testing and formulation, but not a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of the Study that Proves Acceptance Criteria are Met:
The provided 510(k) summary indicates that the "AGC Special Alloy" meets its acceptance criteria by complying with recognized international and European standards for dental alloys and medical devices, specifically:
- ISO 9693: This international standard specifies the requirements for dental casting gold alloys. The document explicitly states the device "fully complies to the international standard ISO 9693."
- European Directive 93/42/ECC: This directive concerns medical devices and sets essential requirements for their safety and performance. The document states the device "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."
Beyond these overarching compliance statements, the summary also mentions specific performance characteristics derived from material testing and formulation:
- High corrosion resistance: This would be demonstrated through standardized corrosion tests.
- Excellent biocompatibility: This would typically be proven through biocompatibility tests (e.g., cytotoxicity, sensitization, irritation tests) in accordance with relevant ISO standards for medical devices (e.g., ISO 10993 series).
- Suitability for specific dental applications: The range of indications (inlays, onlays, crowns, bridges, partials, telescopic/milling work, laser welding) implies mechanical properties (e.g., strength, hardness, elasticity) that meet the requirements for these uses, along with bond strength to ceramics and composites. These properties would be verified through appropriate mechanical testing and bonding studies.
- Absence of copper: This is a compositional specification verified through material analysis.
In essence, the "study" proving acceptance criteria in this context is the comprehensive material characterization and testing program conducted by the manufacturer to ensure the alloy's physical, chemical, and biological properties meet the requirements of relevant regulatory standards and its intended use. The 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device (BioPorta G, K012826) by showing that it meets these established material standards and has comparable performance characteristics.
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K023392
AGC Special Alloy
510 (k) Summary 5.
DEC 0 6 2002
| Submitter of 510(k): | Wieland Dental + Technik GmbH & Co. KG |
|---|---|
| Schwenninger Str. 13 | |
| D-75179 Pforzheim | |
| Germany | |
| Phone: +49-7231-3705-0 |
| Contact person: | Dr. Gerhard Polzer |
|---|---|
| Phone: | +49-7231-3705-219 |
| Fax: | +49-7231-357959 |
| e-mail: | gerhard.polzer@wieland-dental.de |
Date of Summary: 2002-10-05
Trade name:
AGC Special Alloy
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed equivalent device: BioPorta G
510(k) number: K 012826
Device description
AGC Special Alloy is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing 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.
AGC Special Alloy 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.
AGC Special Alloy 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. The text is in all caps and is arranged in a circular fashion to match the shape of the circle.
Public Health Service
DEC 0 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. K Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K023392
Trade/Device Name: AGC Special Alloy Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: October 05, 2002 Received: October 09, 2002
Dear Dr. Polzer,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Gerhard Polzer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski
Timonay wski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
AGC Special Alloy
Device Name:
Indications For Use:
AGC Special Alloy is a gold-platinum 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
- Long span bridges
- Pontics for AGC bridges
- Removable partials
and can be used for
- . Telescopic and millinq work
AGC Special Alloy can be veneered with suitable dental ceramics as well as with dentalcomposites.
In addition, AGC Special Alloy, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of AGC Special alloy are joined to form dental restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use_.... |
| RSBetz DDS for Dr. Susan Runner (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, |
Infection Control, Dental Devices
510(k) Number: K023392
§ 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.