(77 days)
Not Found
Not Found
No
The summary describes a dental casting alloy and does not mention any AI or ML components or functionalities.
No.
The device is a dental casting alloy used to fabricate restorations, which is a material rather than a device intended to treat or cure a disease.
No
The device is described as a "Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration," which is a material used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a "Gold reduced palladium based casting alloy," which is a physical material, not software.
No, 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 restorative purposes, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description "Gold reduced palladium based casting alloy" further confirms it's a material for dental restorations.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device falls under the category of a dental material used for fabrication of prosthetics.
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
Gold reduced palladium based 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
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Key Metrics
Not Found
Predicate Device(s)
Aurium Aurolite 2A
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
Image /page/0/Picture/0 description: The image shows the logo for AUREX. The logo consists of two overlapping triangles, one slightly offset from the other, creating a three-dimensional effect. Below the triangles, the word "AUREX" is written in capital letters. The logo is black and white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
-14-
zasto
510 (k) Summary
Trade name: Common name: Classification name: Class ification number:
HIPALLAUR 19 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT
Legally marketed device: Aurium Aurolite 2A Description of the device: Gold rdeuced palladium based casting alloy Intended use of the device: Type 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 | Ag | Pd | Sn | In | Fe | Mn | Ru | |
| Legal | Aurolite 2A | 13.5 | 27.8 | 49.5 | 4.6 | 4.4 | 0 | 0 | x |
| New | Hipallaur 19 | 19 | 10.4 | 57.1 | 10.3 | 2.3 | 0.3 | 0.5 | 0.1 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | | | Melting point
range (°C) | | Hardness
(Vickers
5/30) | | Yield
strength
(MPa) | | Elongation
(%) | | Density
(g/cm3) |
|--------------|-----------------------------|--------------|-----------------------------|---------------|-------------------------------|----------------|----------------------------|---------|-------------------|--------------|--------------------|
| | Name | solid. | liquid | . soft soft a | hard | soft soft soft | hard | soft | hard | | 11.7 |
| Legal
New | Aurolite 2A
Hipallaur 19 | 1270
1210 | 1335
1250 | 170
270 | 370 | 462
640 | 670 - | 8
20 | | 14.6
13.7 | 12.3 |
Discussion
Both alloys have the same constituents with the exception of two minor ones, i.e. Mn and Fe in Hipallaur 19. Nevertheless, these are oxidized out of the alloy during melting.
- Nevelliedess, aloos are onlines on ent (67.1 % vs. 63 %) and less silver and base metals.
Conclusion
AND A STATE A CALL A CARA A CARA
On the basis of the constitution the new alloy is very similar to Aurolite 2A, and it may be assumed that due to the higher noble metal content Hipallaur may have slightly better corrosion resistance.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human figures or stylized birds in flight. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries. (PTY) LTD. . P.O. Box 509 ················ Edenvale 1610 Republic of South Africa
K972950 Re : Hipallaur 19 Trade Name: 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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: "
2
Page 2 - Mr. Davis ... .
this response to your premarket notification submission does not affect any obligation you might have under sections 531 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.fya.gov/cdrh/dsmamain.html".
Sincerely Yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ HIPALLAUR 19
Indications For Use:
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Image /page/3/Picture/4 description: The image shows a black and white drawing of a sphere. A crescent shape is cut out of the left side of the sphere. The crescent shape is white, while the rest of the sphere is black.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rivera
(Division Sign-Off) Division of Denial, Infection Control, and General Hospital Devices ાળ 510(k) Number _
Prescription Use_ Per 21 CFR 801.109) OR
Over-The-Counter Use