(69 days)
Dental casting alloy for making restoration.
High gold casting alloy
The provided document is a 510(k) summary for a dental casting alloy, AURECAST 74. It describes the device, its intended use, and a comparison to a legally marketed predicate device (Jelenko Modulay). This document does not describe a study involving an AI/ML device or its acceptance criteria, performance, or validation methods.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies for an AI/ML device from this text. The provided text is purely a regulatory submission for a traditional medical device (dental alloy).
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AUG 28 1997
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
Image /page/0/Picture/3 description: The image shows a logo with the word "AUREX" in bold, sans-serif font at the bottom. Above the word, there is a geometric shape that appears to be composed of three overlapping triangles or chevrons, creating a layered effect. To the right of the logo, there are some blurred or faded text elements that are difficult to read due to the image quality.
510 (k) Summary
AURECAST 74 Trade name: Dental casting alloy Common name: Gold based alloys and precious metal alloys for clinical use Classification name: ETI. Class ification number:
Legally marketed device: Jelenko Modulay Description of the device: High gold casting alloy Intended use of the device: Type III restorations
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 and ISO 1562
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Pd | Cu | Zn | Sn | Ir | |
| Legal | Modulay | 77 | 13.5 | 0 | 1 | 8 | x | 0 | x |
| New | Aurecast 74 | 74.1 | 13.4 | 1.6 | 2.3 | 6.8 | 1 | 0.7 | 0.1 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting point range (°C) | Hardness (Vickers 5/30) | Yield strength (MPa) | Elongation (%) | Density (g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | ||
| Legal | Modulay | 900 | 940 | 135 | 262 | 44 | 15.8 | |||
| New | Aurecast 74 | 930 | 970 | 130 | 210 | 310 | 390 | 43 | 26 | 16.3 |
Discussion
The noble metal content is equivalent. There is a negligable difference in the other constituents, Aurecast 74 contains Sn for improved brazing properties.
Conclusion
In practical respect are the two alloys identical.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 28 1997
Mr. Jerome D. Davis Manaqing Director Aurex Precious Metal Industries (PTY) LTD P.O. Box 509 Edenvale 1610 -Republic of South Africa
K972941 Re : Trade Name: Aurecast 74 II Requlatory Class: Product Code: EJT Dated: June 13, 1997 Received: June 20, 1997
Dear Mr. Davis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Davis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K9729 )evice Name: AURECAST 74
Indications For Use:
Dental casting alloy for making restoration.
( 人/ の )
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dentai, Infection Control,
and General Hospital Devices
પિત 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.