(77 days)
Not Found
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of software, image processing, or AI/ML terms.
No.
The device is a dental casting alloy used in combination with dental ceramics for the fabrication of metallo-ceramic restorations, which does not inherently have a therapeutic effect on the body. Instead, it is a material used in the creation of a dental prosthesis.
No
The device is described as a "Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration," which indicates it is a material used for restoration, not for diagnosis.
No
The device description clearly states it is a "Low gold palladium based 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 "Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration." This describes a material used in the creation of a dental prosthesis, not a test performed on a sample from the human body to provide information about a physiological state or disease.
- Device Description: The device is described as a "Low gold palladium based casting alloy." This is a material used in manufacturing.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing diagnostic information about a patient's health.
- Reagents, calibrators, or controls typically associated with IVDs.
The information provided clearly indicates this is a dental material used in the fabrication of restorations, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Low gold 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of composition:
Legal: Freedom Plus: Au (2%), Pd (78.4%), Cu (8%), In (6%), Ga (5%), Ru (x
§ 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 graphic above the word "AUREX". The graphic appears to be composed of three overlapping triangles, creating a complex geometric shape. 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
SEP - 5 1997
-18-
510 (k) Summary
Trade name: Common name: Classification name: Class ification number:
PALAUREX 78 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT
Legally marketed device: Jelenko Freedom Plus Description of the device: Low gold 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 | Pd | Cu | In | Ga | Ru | |
| Legal | Freedom Plus | 2 | 78.4 | 8 | 6 | 5 | x |
| New | Palaurex 78 | 2 | 77.8 | 13 | 7 | 0.2 |
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 Freedom Plus | 1170 | 1300 | 265 | 565 | 30 | 13.9 | 10.8 | |||
| New Palaurex 78 | 1150 | 1190 | 330 | 380 | 780 | 850 | 12 | 2 | 14.3 | 10.6 |
Discussion
The noble content metal is high (80%) in both alloy, with almost identical breakdown to the respective elements.
Palaurex 78 has two base metal elements, Cu and Ga: Freedom Plus has In as well.
Conclusion
On the basis of the identical major elements and high noble metal content similar biological effect may be expected from both alloys.
TÜV
CERT
Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07) Mone .. Samore and Rotinoro of Denning Motors for Dontal Toustlars
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle in a circular fashion.
SEP - 5 1997
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
K972954 Re: Palaurex 78 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 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 regulations 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
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):
D
Device Name: PALAUREX 78
Indications For Use:
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Image /page/3/Picture/5 description: The image shows a solid black circle. The circle is slightly irregular in shape, with a few minor imperfections along its perimeter. The background is white, providing a stark contrast to the black circle. The image is simple and minimalist, focusing solely on the shape and color of the circle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Supper Rioner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita! Devices 510(k) Numbe
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)