(159 days)
Dental Casting alloy used for fabrication of metallo-ceramic restorations in conjunction with dental ceramics of thermal expansion co-efficient not less than 16.3 x 10 -9K. (25 - 600°C)
High gold casting alloy
The provided text describes the 510(k) summary for AURENORM 68, a dental casting alloy, and its comparison to a legally marketed predicate device, Jelenko Allround 4. The focus is on demonstrating substantial equivalence based on technological characteristics rather than clinical performance from a study. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/medical imaging performance metrics cannot be fully answered in the typical sense.
However, I can extract and structure the information provided in a way that aligns with the spirit of your request, interpreting "acceptance criteria" as the comparison points for demonstrating substantial equivalence and "reported device performance" as the properties of AURENORM 68.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices applying for 510(k) clearance, the "acceptance criteria" for demonstrating substantial equivalence often involve showing that the new device has similar technological characteristics (composition, physical, and mechanical properties) and intended use as a predicate device. The "study" in this context is the comparison of these characteristics.
| Acceptance Criteria (Predicate Device Values) | Reported Device Performance (AURENORM 68 Values) | Property |
|---|---|---|
| 69.0 wt% | 68.9 wt% | Gold (Au) Composition |
| 13.9 wt% | 12.1 wt% | Silver (Ag) Composition |
| 9.0 wt% | 9.9 wt% | Platinum (Pt) Composition |
| 4.5 wt% | 6.9 wt% | Copper (Cu) Composition |
| 2.0 wt% | 0.9 wt% | Zinc (Zn) Composition |
| 1.6 wt% | 0.7 wt% | Indium (In) Composition |
| 0.0 wt% | 0.6 wt% | Ruthenium (Ru) Composition |
| < 1 wt% | 0.0 wt% | Iridium (Ir) Composition |
| 900 °C | 939 °C | Melting point range (solidus) |
| 970 °C | 977 °C | Melting point range (liquidus) |
| Not specified | 160 Vickers (soft) | Hardness (Vickers 5/30) |
| 260 Vickers (hard) | 240 Vickers (hard) | Hardness (Vickers 5/30) |
| Not specified | 410 MPa (soft) | Yield strength |
| 592 MPa (hard) | 650 MPa (hard) | Yield strength |
| Not specified | 14 % (soft) | Elongation |
| 10 % (hard) | 8 % (hard) | Elongation |
| 16.9 x 10⁻⁶/°C | 16.4 x 10⁻⁶/°C | CTE (x10⁻⁶/°C) |
| 15.8 g/cm³ | 16.2 g/cm³ | Density (g/cm³) |
| High, in excess of 78% | High, in excess of 78% (>78% - calculated from 68.9+12.1+9.9 = 90.9%) | Noble Metal Content |
| Similar to legally marketed device | Claimed "basically similar composition and physical, mechanical properties" | Overall Similarity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to the provided document. The submission is a 510(k) summary for a material (dental alloy) and does not involve a clinical study with a test set of data like an AI/imaging device would. The "test methods applied" refer to industry standards for material testing (ANSI/ADA 5, ISO 1562, and 9693), not a clinical trial or performance evaluation using patient data.
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. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on medical images) is not relevant for this type of device submission. The "ground truth" here is the measured physical and chemical properties of the alloy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set is described.
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 a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material submission, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be the empirical measurements of the chemical composition and physical/mechanical properties of the alloy (Aurenorm 68 and Allround 4) adhering to the specified industry standards (ANSI/ADA 5, ISO 1562, and 9693).
8. The sample size for the training set
Not applicable. There is no training set in the context of this device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the document.
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Image /page/0/Picture/0 description: The image shows a logo for AUREX. The logo consists of a stylized mountain range above the word "AUREX". The mountain range is made up of two overlapping triangles, and the word "AUREX" is written in a simple sans-serif font.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
NOV 26 1997
510 (k) Summary
AURENORM 68 Trade name: Dental casting alloy Common name: Gold based alloys and precious metal alloys for clinical use Classification name: Class ification number: EJT
Legally marketed device: Jelenko Allround 4 Description of the device: High gold casting alloy Intended use of the device: Type IV restorations and low fusing porcelain veneering
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 , ISO 1562 and 9693
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Cu | Zn | In | Ru | I | |
| Legal | Allroound 4 | 69 | 13.9 | 9 | 4.5 | 2 | 1.6 | 0 | x |
| New | Aurenorm 68 | 68.9 | 12.1 | 9.9 | 6.9 | 0.9 | 0.7 | 0.6 | 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 (%) | CTE (x10-6/°C ) | Density (g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | |||
| Legal | Allround 4 | 900 | 970 | 260 | 592 | 10 | 16.9 | 15.8 | |||
| New | Aurenorm 68 | 939 | 977 | 160 | 240 | 410 | 650 | 14 | 8 | 16.4 | 16.2 |
Discussion
Both alloys consist of the same major elements. The noble metal content is very high, in excess of 78% and differs only approx. 1 %. The difference in base metal content is even less, i.e. 0.6 %.
Conclusion
Basically similar composition and physical, mechanical properties. On the basis of compositional similarity it may be assumed that the biological effect is also similar.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J.D. Davis. ·C.E.O. Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
Re : K972945 Trade Name: Aurenorm 68 Requlatory Class: II Product Code: EJS September 16, 1997 Dated: Received: September 30, 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, Druq, 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, qood 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. ਕੇ 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 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. 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 through 342 or the not 101 voisions, or other Federal laws or regulations.
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 regulation (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
U. Ulatowski
Timothy A Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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22-5011-1193
Page_1__of_1_
Concession of the consisted on the consisted to the status
510(k) Number (if known): K972945
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Dental Casting alloy used for fabrication of metallo-ceramic restorations in conjunction with dental ceramics of thermal expansion co-efficient not
less than 16.3 x 10 -9K. (25 - 600°C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrentse of CDRH, Office of Device Evaluation (ODE) unovi ADDING (Division Sign-Off) Division if Dental Infection Control,
and General Hospial Devices 167794 510(k) Number_
Prescription Use (Per 21 CFR 801.109)
ેન્દ્રનો ભાગના પાકની ખેત
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.