(66 days)
Not Found
Not Found
No
The device is a dental casting alloy, a material, and the description and performance studies focus on its material properties, not software or algorithmic capabilities. There is no mention of AI, ML, image processing, or data analysis.
No
The device is a dental casting alloy used for making dental restorations and appliances. It is a material used in the creation of a medical device, but it is not a therapeutic device itself. Its function is to create a restoration, not to treat a condition directly.
No
Explanation: The device is described as a "Dental casting alloy for making dental restorations and appliances," indicating it is a material used for treatment or prosthetic purposes, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a "Low gold, 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 a test performed on a sample taken from the body to diagnose a condition.
- Device Description: It's described as a "Low gold, silver-palladium based casting alloy." This is a material composition, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided clearly indicates a dental material used for fabrication, not a diagnostic test.
N/A
Intended Use / Indications for Use
Dental casting alloy for making dental restorations and appliances.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Low gold , 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 composition and physical and mechanical properties between the new device and the legally marketed device were performed. The major components are identical, and minor differences in Zn, Ru, and Ir have negligible effects.
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.
Aurium Aurolite CB-25
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 for AUREX. The logo consists of three overlapping triangles, forming a complex geometric shape. Below the triangles, the word "AUREX" is written in capital letters, with a line underneath it. The logo is black and white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
AUG 25 1997
510 (k) Summary
AURECAST 10 Trade name: Common name: Dental casting alloy Classification name: Gold based alloys and precious metal alloys for clinical use Class ification number: EJT
Legally marketed device: Aurium Aurolite CB-25 Description of the device: Low gold , 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 | Ru | Ir | |
| Legal | AuroliteCB-25 | 10 | 59.9 | 20 | 9 | x | 0 | x |
| New | Aurecast 10 | 10 | 59.9 | 20 | 9 | 1.0 | 0.1 | 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 | AuroliteCB-25 | 1000 | 1030 | 160 | 270 | 410 | 560 | 10 | 3 | 10.6 |
| New | Aurecast 10 | 1000 | 1030 | 160 | 270 | 410 | 560 | 15 | 8 | 10.6 |
Discussion
The major components of the two alloys are identical and their concentration is the same. The only difference is in the small amount of Zn and the grain refiners such as Ru and Ir. These minor differences have negligible effect upon the alloys.
Conclusion
The two alloys are practically identical
Image /page/0/Picture/18 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rectangular box with rounded corners. Below the text, it says "ISO 9001". There are two curved lines above the text.
Aurex Precious Metal Industries (Pty) Limited (Reg. No. 88/04891/07) Manufacturers and Refiners of Precious Metals for Dental, Jewellery and Industrial applications Directors: J.D. Davis (Managing) S. Engelberg D. Wagenheim
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of a bird with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
Re : K972938 Trade Name: Aurecast 10 Requlatory Class: II Product Code: EJT Dated: June 13, 1997 Received: June 20, 1997
AUG 25 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 requirements, 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. 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) 594-4692. 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
Time A 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 10 levice Name:
Indications For Use:
Dental casting alloy for making dental restorations and appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swan Runner
Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number
-Prescription Use y/2 er 21 CFR 801.109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)