(90 days)
Argen Argedent Bio Yellow PF
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of AI or ML.
No
The device is a dental casting alloy used for restoration, not for treating a disease or condition.
No
This device is a dental casting alloy used for fabrication of metallo-ceramic restorations, which is a material used in treatment rather than a tool for diagnosis.
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 used in combination with dental ceramics for fabrication of metallo-ceramic restoration." This describes a material used in the mouth for dental restorations, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: "High gold casting alloy" further reinforces that it's a material for dental work.
- 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 analytes
- Providing diagnostic information
The information provided clearly indicates a dental material used for fabrication, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of composition, physical and mechanical properties between the subject device (Aurelux BioY85PF) and the legally marketed device (Argen Argedent Bio Yellow PF).
Key results:
Noble metal content is very high (excess of 98%).
Total base metal content is very low, with Zn as the major element (1.8% and 1.5% respectively).
Argedent contains Ta and Mn, which are expected to oxidize and eliminate from the alloy during melting.
Conclusion: "On the basis of the very high noble metal content and essentially same constitution it may be expected that the new alloy perform very similarly to Argident B Y PF."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Argen Argedent Bio Yellow PF
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
K 972949
Image /page/0/Picture/1 description: The image shows the logo for AUREX. The logo consists of the word "AUREX" in bold, capital letters, with a stylized graphic above it. The graphic appears to be two overlapping triangles, creating a mountain-like shape.
P.O. Box 509 Edenvale 1610
Republic of South Africa
Telephone: +27 (11) 609-8640
Telefax: +27 (11) 452-3918
2018-08-07 11:12:13:13 11:11:13 11:11:13 11:11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:
SEP 1 8 1997
510 (k) Summary
Trade name: Common name: Classification name: Class ification number:
AURELUX Bio Y85PF Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT
Legally marketed device: Argen Argedent Bio Yellow PF Description of the device: High gold casting alloy Intended use of the device: Type II to IV restoration with porcelain veneering
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Pt | Zn | Ta | In | Ir | Rh | Mr | ||
| Legal | Argedent Bio Y PF | 86.5 | 10.4 | 1.5 | 0.3 | 0.2 | 0 | 0.9 | 0.1 | |
| New | Aurelux BioY85PF | 84.5 | 12 | 1.8 | 0 | 0.5 | 1.2 | 0 | 0 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting point
range (oC) | Hardness
(Vickers
5/30) | Yield
strength
(MPa) | Elongation
(%) | CTE
( x10-
6/°C ) | Density
(g/cm3) | | | | | |
|-------|-----------------------------|-------------------------------|----------------------------|-------------------|-------------------------|--------------------|------|------|---|------|------|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | | | |
| Legal | Argedent B Y PF | 1040 | 1130 | 180 | 250 | 650 | 750 | 8 | 5 | 14.5 | 18.6 |
| New | Aurelux | 1027 | 1079 | 120 | 220 | 280 | 460 | 17 | 7 | 14.4 | 18.8 |
| | BioY85PF | | | | | | | | | | |
Discussion
The noble metal content is very high, in the excess of 98 %. Total base metal content is therefore very low, the major element of it in both alloys is Zn with 1.8 and 1.5 % respectively. Argedent contains also Ta and Mn, which most probably are oxidized and eliminated from the alloy during melting.
Conclusion
On the basis of the very high noble metal content and essentially same constitution it may be expected that the new alloy perform very similarly to Argident B Y PF.
Image /page/0/Picture/22 description: The image shows a logo with the text "TUV CERT" in bold, black letters. The "TUV" is stacked on top of "CERT". The logo is enclosed in a rounded square border. There are two curved lines above the text, adding a design element to the logo.
Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07)
-13-
1
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
Re : K972949 Aurexlux Bio Y85PF Trade Name: Requlatory Class: II Product Code: EJS 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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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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 qeneral 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 Cucenita ffor
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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