(69 days)
Jelenko Benchmark I
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of software, image processing, AI, or ML.
No
Explanation: The device is a dental casting alloy used for making restorations, which is a material used in dentistry, not a therapeutic device designed to treat or alleviate a disease or condition. Its function is to form a restoration, similar to a filling or crown.
No
Explanation: The device is described as a "Dental casting alloy for making restoration," indicating it is a material used for treatment rather than diagnosis. The provided information focuses on its material properties and performance studies related to its physical and mechanical characteristics, not its ability to identify or monitor a disease or condition.
No
The device description clearly states it is a "High gold casting alloy," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Dental casting alloy for making restoration." This describes a material used in the creation of dental prosthetics, which is a manufacturing process, not a diagnostic test performed on a biological sample.
- Device Description: The description "High gold casting alloy" further reinforces that it's a material for fabrication.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided clearly indicates a device used in the manufacturing of dental restorations, which falls under the category of dental materials, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Dental casting alloy for making restoration.
Product codes
EJT
Device Description
High gold casting alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Jelenko Benchmark I
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
G 20
Image /page/0/Picture/2 description: The image shows a logo for "AUREX". The logo consists of two overlapping triangles, one slightly above the other, both filled in with black. Below the triangles, the word "AUREX" is written in a bold, sans-serif font. The overall design is simple and geometric.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
AURECAST 83 Trade name: Dental casting alloy Common name: Gold based alloys and precious metal alloys for clinical use Classification name: EJT Class ification number:
Legally marketed device: Jelenko Benchmark I Description of the device: High gold casting alloy Intended use of the device: Type II 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 | Cu | Zn | In | Ir | |
| Legal | Benchmark I | 83 | 8 | 1 | 5.2 | 0 | 2.2 | x |
| New | Aurecast 83 | 83.1 | 6.7 | 0 | 8.7 | 1.5 | 0 | 0 |
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 | BenchmarkI | 900 | 940 | 115 | 152 | 50 | 16.5 | |||
| New | Aurecast 83 | 920 | 940 | 110 | 110 | 290 | 290 | 38 | 38 | 17.1 |
Discussion
Practically identical, very high gold content in both alloys. The major constituents are the same. The slightly higher Cu and Zn content of Aurecast 83 was intended to give increased strength and hardness. Due to the very high gold content both alloys have extreme corrosion and tarnish resistance.
Conclusion
With its very high concentration gold has a dominant influence on the alloys' properties. Owing to the practical equivalence of the gold concentration the two alloys should have similar chemical resistance and biological effect.
-8-
1
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 eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 28 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) LTD P.O. Box 509 Edenvale 1610 Republic of South Africa
K972942 Re: Aurecast 83 Trade Name: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 regulation (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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
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 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.fdfa.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
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
AURECAST 83 levice Name:
Indications_For Use:
Dental casting alloy for making restoration.
FOR USE WITH DENTAL PORCELAIN ) ( NOT (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Olf) Division of Dental, In and General Host 510(k) Number
Prescription Use er 21 CFR 801.109)
: 参考
OR
Over-The-Counter Use_