(77 days)
Not Found
None
No
The summary describes a dental casting alloy, a material, and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a dental casting alloy used for restoration, which is a material rather than a device designed to deliver therapy.
No
This device is described as a "Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration." This indicates it is a material used for restoration, not for diagnosis.
No
The device description clearly states it is a "Palladium silver 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 for fabricating dental restorations, which are used in the mouth, not for testing samples from the body in a lab setting.
- Device Description: It's a dental casting alloy, a material used in the manufacturing process of a medical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies mentioned relate to material properties (as per ANSI/ADA and ISO standards), not diagnostic accuracy.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This dental alloy does not fit that description.
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
Palladium silver 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aurium Aurolite IK
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
SEP 1997
Image /page/0/Picture/1 description: The image shows a logo with a stylized mountain range above the word "AUREX". The mountain range is composed of three overlapping triangles, creating a sense of depth and complexity. The word "AUREX" is written in a bold, sans-serif font, with a horizontal line underlining the text.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
-19-
510 (k) Summary
Trade name: Common name: Classification name: Class ification number: EJT
PALCERAM 56 Dental casting alloy Gold based alloys and precious metal alloys for clinical use
Legally marketed device: Aurium Aurolite IK Description of the device: Palladium silver 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 | Ag | Pd | Sn | In | Zn | Ru | |
| Legal | Aurolite IK | 30 | 58 | 6 | 4 | x | x |
| New | Palceram 56 | 32 | 56.5 | 3.9 | 7.3 | 0 | 0.3 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting point range (oC) | Hardness (Vickers 5/30) | Yield strength (MPa) | Elongation (%) | CTE (x10-6/oC) | Density (g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | |||
| Legal | Aurolite IK | 1232 | 1282 | 260 | 552 | 14 | 14.9 | 11.3 | |||
| New | Palceram 56 | 1200 | 1230 | 200 | 265 | 470 | 600 | 8 | 3 | 14.9 | 11.1 |
Discussion
The same constituents can be found in both alloys save a minor concentration of Fe vs. Zn.
Conclusion
Identical main elements and the similarity of their content can result in similar chemical and biological effect.
Image /page/0/Picture/20 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rounded square. The text is in a bold, sans-serif font. The logo is black and white.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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
K972955 Re : Palceram 56 Trade Name: Regulatory Class: II Product Code: EJT June 13, 1997 Dated: 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 able beated in the enouble 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, 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 requlation 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
2
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 ma 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
Timot U 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):
evice Name:
Indications For Use:
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Simmons
(Division Sion-GM 510
Prescription Use Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)