(67 days)
Dental casting alloy for making dental restorations and appliances.
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)
Division ! 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use ------
High gold casting alloy
This report is a 510(k) summary for a dental casting alloy, not a study evaluating an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.
However, I can extract information related to the comparison of the new device to a legally marketed predicate device, which can be seen as an analog to "acceptance criteria" for demonstrating substantial equivalence based on physical and chemical properties.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" for a new device like "Aurecast Bio 69PF" are demonstrating substantial equivalence to a legally marketed predicate device ("Jelenko Benchmark IV"). This is achieved by showing comparable composition and physical/mechanical properties. The tables below outline these comparisons.
| Criterion (Predicate Device: Jelenko Benchmark IV) | Reported Device Performance (Aurecast Bio 69PF) |
|---|---|
| Composition (weight%) | |
| Au: 70 | Au: 69.7 |
| Ag: 12 | Ag: 14 |
| Pt: 5 | Pt: 3.8 |
| Cu: 12.5 | Cu: 10.8 |
| Zn: 0 | Zn: 1.4 |
| In: <1% | In: 0 |
| Ir: <1% | Ir: 0.3 |
| Physical and Mechanical Properties | |
| Melting point range (°C) | |
| Solidus: 890 | Solidus: 878 |
| Liquidus: 930 | Liquidus: 905 |
| Hardness (Vickers 5/30) | |
| Soft: 195 | Soft: 180 |
| Hard: 285 | Hard: 250 |
| Yield strength (MPa) | |
| Soft: 352 | Soft: 320 |
| Hard: 670 | Hard: 485 |
| Elongation (%) | |
| Soft: 40 | Soft: 30 |
| Hard: 9 | Hard: 6 |
| Density (g/cm3) | 15.3 |
| 15.5 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. Standard material testing typically uses multiple specimens to ensure reproducibility, but the exact number isn't mentioned in this summary.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. The applicant is based in South Africa.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a material science comparison, not a diagnostic or AI study involving human expert ground truth. The "ground truth" here is the measured physical and chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a material science testing, not a clinical trial requiring adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the directly measured chemical composition (weight %) and physical/mechanical properties (melting point, hardness, yield strength, elongation, density) as determined by standardized test methods (ANSI/ADA 5 and ISO 8891).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device, so there is no training set.
Summary of the study/comparison:
The "study" presented here is a direct comparison of the chemical composition and physical/mechanical properties of the new device (Aurecast Bio 69PF) against a legally marketed predicate device (Jelenko Benchmark IV). The manufacturer asserts that the "major constituents up to 98% are the same" and that the "small amount of indium... cannot cause any considerable difference." The conclusion is that "due to the similarity of the constitution it may be assumed that the chemical behaviour and the biological effect should be quite similar," thus establishing substantial equivalence. The test methods applied for these measurements were "as in ANSI/ADA 5 and ISO 8891."
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Image /page/0/Picture/1 description: The image shows a logo for "AUREX". The logo consists of three overlapping triangles, forming a complex geometric shape. The word "AUREX" is printed in bold, uppercase letters below the geometric shape. The logo appears to be in black and white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
AUG 26 1997
510 (k) Summary
AURECAST BIO 69 PF 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 IV Description of the device: High gold 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:
-6-
| ALLOY | COMPOSITION (weight%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Cu | Zn | In | Ir | ||
| Legal | Benchmark IV | 70 | 12 | 5 | 12.5 | 0 | x | x | |
| New | Aurecastbio69PF | 69.7 | 14 | 3.8 | 10.8 | 1.4 | 0 | 0.3 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting pointrange (°C) | Hardness(Vickers5/30) | Yieldstrength(MPa) | Elongation(%) | Density(g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | ||
| Legal | Benchmark IV | 890 | 930 | 195 | 285 | 352 | 670 | 40 | 9 | 15.5 |
| New | Aurecast | 878 | 905 | 180 | 250 | 320 | 485 | 30 | 6 | 15.3 |
| Bio60PE |
Discussion
The major constituents up to 98% are the same. The same within 0.1%. Both alloys are built up from the same elements save a small amount of indium, which cannot cause any considerable difference.
Conclusion
Due to the similarity of the constitution it may be assumed that the chemical behaviour and the biological effect should be quite similar
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
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
AUG 26 1597
Re: K972940 Trade Name: Aurecast Bio 69PF Requlatory Class: II EJT Product Code: 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 of the Act. The general controls provisions 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. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) ior 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 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 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 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 W. Ulatowski
Timo 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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K972940 510(k) Number (if known): __
Device Name: AURECAST BIO 69PF
Indications For Use:
:
ప్లిప్ల
Dental casting alloy for making dental restorations and appliances.
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)
Suar Purari
Division ! 510(k) Number
Prescription Use
er 21 CFR 801.109)
OR
Over-The-Counter Use ------
§ 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.