(88 days)
Dental casting alloy for making restoration.
High gold casting alloy
I am sorry, but the provided text describes a 510(k) submission for a dental casting alloy named AURECAST 92. This document is a regulatory submission for a material, not a medical device that would involve a study with acceptance criteria, sample sizes, expert ground truth, or human-in-the-loop performance as you've requested.
The document focuses on comparing the AURECAST 92 alloy to a legally marketed predicate device (Argenco Bio10) based on composition, physical, and mechanical properties. The acceptance is based on the substantial equivalence of these material properties, rather than performance metrics of a device against specific clinical or diagnostic criteria.
Therefore, I cannot extract the information required for the table and bullet points you provided, as those concepts (like sample size for test sets, ground truth by experts, MRMC studies, standalone performance) are not applicable to the type of device and submission described in the text.
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Image /page/0/Picture/1 description: The image shows a logo with the word "AUREX" in bold, capitalized letters at the bottom. Above the text is a graphic consisting of two overlapping, solid black triangles. The triangles are oriented with their points facing upwards, creating a stylized, abstract design.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
Trade name: AURECAST 92 Common name: Dental casting alloy Gold based alloys and precious metal alloys for clinical use Classification name: EIT. Class ification number:
Legally marketed device: Argen Argencco Bio 10 Description of the device: High gold casting alloy Intended use of the device: Type I 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 | Cu | |
| Legal | ArgencoBio10 | 91.7 | 6 | 2.3 |
| New | Aurecast 92 | 91.7 | 6 | 2.3 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting pointrange (oC) | Hardness(Vickers5/30) | Yieldstrength(MPa) | Elongation(%) | Density(g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | ||
| Legal | Argenco Bio10 | 1010 | 1030 | 70 | 220 | 45 | 18.2 | |||
| New | Aurecast 92 | 1010 | 1030 | 70 | 75 | 100 | 360 | 45 | 22 | 18.2 |
Discussion
The two alloys are identical.
TÜV
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
Re: K972943 Trade Name: Aurecast 92 Requlatory Class: II 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, Druq, and Cosmetic Act (Act). 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Paqe 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 diaqnostic 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,
Patricia Cocciante // foc
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): _
AURECAST 92 Device Name:
Indications For Use:
Dental casting alloy for making restoration.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rimmer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.