(159 days)
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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 fabricating restorations, which is a material used in a therapeutic procedure rather than a therapeutic device itself.
No
The device is a dental casting alloy used for restorations, not for diagnosing medical conditions. The provided information focuses on its material properties and intended use in fabricating dental prosthetics, not on detection, diagnosis, or monitoring of diseases.
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 for fabricating dental restorations (metallo-ceramic restorations) using a casting alloy. This is a material used in the creation of a medical device (the dental restoration), not a test performed on a biological sample to diagnose a condition.
- Device Description: It's described as a "High gold casting alloy," which is a material, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This dental casting alloy does not fit this description.
N/A
Intended Use / 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)
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
High gold casting alloy
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of composition and physical and mechanical properties between the subject device (Aurenorm 68) and the legally marketed device (Jelenko Allround 4).
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 %.
The alloys have basically similar composition and physical, mechanical properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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 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.
Image /page/0/Picture/20 description: The image shows a logo with the letters "TUV" in bold, sans-serif font. Below the letters, there is some text that is difficult to read. The logo is enclosed in a rectangular shape with rounded corners, and there are three lines outlining the shape. The logo appears to be a certification mark or quality seal.
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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
Image /page/1/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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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)