(66 days)
Not Found
Not Found
No
The summary describes a dental casting alloy with no mention of software, image processing, or AI/ML terms.
No.
The intended use is for making dental restorations and appliances, which are typically structural components and not therapeutic in nature. The device description is a casting alloy, which is a material used to manufacture parts, not a device that provides therapy.
No
Explanation: The device is described as a "Dental casting alloy for making dental restorations and appliances." This is a material used for treatment (restorations) rather than for diagnosing a disease or condition. The performance studies focus on mechanical properties of the alloy, not diagnostic accuracy.
No
The device description clearly states it is a "Silver-palladium based 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 dental restorations and appliances." This describes a material used in the mouth for structural purposes, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: It's a "Silver-palladium based casting alloy," which is a material used in manufacturing dental devices.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided clearly indicates a device used in the fabrication of dental prosthetics, which falls under the category of dental materials, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Dental casting alloy for making dental restorations and appliances. is not indicated for use with don't a posislaw, (this ally
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Silver-palladium based 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of physical and mechanical properties were tested. The mechanical properties of the two alloys are very similar (especially tensile properties).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Jelenko Maestro
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a logo with two overlapping triangles at the top and the word "AUREX" at the bottom. The triangles are solid black and appear to be slightly offset from each other. The word "AUREX" is in a bold, sans-serif font, and there is a horizontal line directly underneath it. 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
AUG 25
510 (k) Summary
Trade name: COmmon name: Classification name: Class ification number:
AURECAST 2 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EIT
Legally marketed device: Jelenko Maestro Description of the device: Silver-palladium based casting alloy Intended use of the device: Type IV restorations
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 and ISO 8891
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pd | Cu | Zn | Sn | Ir | |
| Legal | Maestro | 3 | 50 | 30 | 15.9 | 1 | 0 | x |
| New | Aurecast 2 | 1.9 | 52.9 | 25.6 | 17.3 | 1 | 1 | 0.3 |
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 Maestro | 940 | 1025 | 225 | 270 | 425 | 606 | 18 | 8 | 10.7 |
| New Aurecast 2 | 885 | 960 | 195 | 220 | 420 | 600 | 17 | 6 | 10.4 |
Discussion
The constituents above 1% are the same. The concentration difference in the major components (silver and palladium) is only 2 and 4 %, respectively.
Conclusion
The mechanical properties of the two alloys are very similar (especially tensile properties), and considering the constitutions it may be assumed that also the chemical properties and biological effect should be very similar.
Image /page/0/Picture/22 description: The image shows a logo with the text "TUV CERT" inside of a rounded square. The letters "TUV" are stacked on top of the word "CERT". The logo is black and white. The logo appears to be a certification mark.
Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07)
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure. The logo is simple and iconic, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis 'Manaqing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
AUG 25 1997
K972936 Re : Aurecast 2 Trade Name: Regulatory 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, 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 reqistration, 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 Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 Chrough 542 or the nee re- rovisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis receir writ as 0 (k) premarket notification. The FDA described in your sie(if promatence of your device to a legally marketed predicate device results in a classification for your marketed predicate device robates to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 crk rares), please contact the Office of vicio diagnostic devices) , productionally, for questions on Compilance at (501) 554 rsing of your device, please contact the Dromocion and adversibling on 1301) 594-4639. Also, please note the Office of Comprised, "Misbranding by reference to the regulation Chercrea, (21 CFR 807.97) -Other general information on your responsibilities under the Act may be Information on your responsible in and Manufacturers Assistance obcarned from ene brying (800) 638-2041 or (301) 443-6597 or at at Its COII-Tree namber (os)/ 350 - 35 - 50 - 6 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
Sincerely yours,
Timothy A. Ulatowski
Timo 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 2 'evice Name:
Indications For Use:
关于
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Dental casting alloy for making dental restorations and appliances. is not indicated for use with don't a posislaw, (this ally
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Concurrence of CDRH, Office of Device Evaluation (ODE)
from the may be the country of the country of the county of the county of the county of the county of the county of the country of the county of the county of the county of t Mino
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_ 897293
Prescription Use W `er 21 CFR 801.109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)