(90 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
High gold casting alloy
The provided document is a 510(k) summary for a dental casting alloy, AURELUX Bio Y85PF. The primary study presented is a comparison between the new device and a legally marketed predicate device (Argen Argedent Bio Yellow PF) based on composition and physical/mechanical properties. The overall conclusion is that the new alloy is "substantially equivalent" to the predicate, implying it meets similar performance characteristics.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a numerical threshold that must be met. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. The performance is reported as a direct comparison of physical and mechanical properties and composition. The implication is that if the new device's properties are comparable to the predicate, it meets the "acceptance criteria" for substantial equivalence.
| Property/Test Method | Predicate Device (Argedent Bio Y PF) | New Device (Aurelux BioY85PF) | Implicit Acceptance Criteria (Comparative) |
|---|---|---|---|
| Composition (weight%) | |||
| Au | 86.5 | 84.5 | Similar (% within reasonable range for the type of alloy) |
| Pt | 10.4 | 12 | Similar |
| Zn | 1.5 | 1.8 | Similar |
| Ta | 0.3 | 0 | Similar (absence noted, considered insignificant due to oxidation/elimination) |
| In | 0.2 | 0.5 | Similar |
| Ir | 0 | 1.2 | Similar |
| Rh | 0.9 | 0 | Similar |
| Mr | 0.1 | 0 | Similar (absence noted, considered insignificant due to oxidation/elimination) |
| Physical/Mechanical Properties | |||
| Melting point range (solid.) | 1040 °C | 1027 °C | Comparable |
| Melting point range (liquid) | 1130 °C | 1079 °C | Comparable |
| Hardness (Vickers 5/30) (soft) | 180 | 120 | Comparable |
| Hardness (Vickers 5/30) (hard) | 250 | 220 | Comparable |
| Yield strength (MPa) (soft) | 650 | 280 | Comparable |
| Yield strength (MPa) (hard) | 750 | 460 | Comparable |
| Elongation (%) (soft) | 8 | 17 | Comparable |
| Elongation (%) (hard) | 5 | 7 | Comparable |
| CTE (x10^-6/°C) | 14.5 | 14.4 | Comparable |
| Density (g/cm³) | 18.6 | 18.8 | Comparable |
Note on "Acceptance Criteria": For an equivalence study like this, the "acceptance criteria" are implicitly that the measured properties of the new device are sufficiently close to those of the predicate device to justify the claim of substantial equivalence. The document concludes: "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." This statement serves as the justification for meeting the implicit acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of manufactured devices tested. Instead, it presents specific compositional percentages and physical/mechanical property values, which are likely derived from laboratory testing of material samples. The number of samples per test is not detailed.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the address of the applicant (Aurex Precious Metal Industries, Republic of South Africa), it's reasonable to infer the testing was conducted there or by a contracted lab. The data is retrospective, as it compares the new device's properties to a pre-existing, legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This study does not involve expert evaluation of clinical images or diagnostic outcomes. The "ground truth" here is objective material science data (composition, physical/mechanical properties) as measured by standard test methods (ANSI/ADA 5 and ISO 9693).
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as this is not a study requiring expert consensus or multiple readings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is a material science comparison for a dental casting alloy, not a diagnostic device involving human readers or cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The ground truth used is objective material science data derived from standardized laboratory test methods (ANSI/ADA 5 and ISO 9693) for:
- Elemental composition (weight percentage of metals)
- Physical properties (melting point range, density, CTE)
- Mechanical properties (hardness, yield strength, elongation)
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or algorithm-based device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
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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 pointrange (oC) | Hardness(Vickers5/30) | Yieldstrength(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)
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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 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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<977 510(k) Number (if known):____
AURELUX BIO Y85PF Device Name:
Indications For Use:
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gerald Skinner
Division of
and
510(k) Number K972949
Prescription Use or 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.