(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Palladium based casting alloy
This document is a 510(k) summary for the Palceram 82SF dental casting alloy, asserting its substantial equivalence to the legally marketed device Argipal. The information provided heavily emphasizes a direct comparison of the new device to the predicate device, rather than defining independent acceptance criteria with separate performance goals.
Therefore, the "acceptance criteria" and "device performance" are presented as a comparison to the predicate device, Argipal, arguing that because Palceram 82SF has "practically identical technological characteristics" it meets the necessary standards. There is no explicit and distinct set of predetermined acceptance criteria independent of the predicate device for this submission.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for Palceram 82SF are implicitly defined by its substantial equivalence to the Argipal alloy. The "reported device performance" for Palceram 82SF is presented as being nearly identical to Argipal.
| Characteristic | Acceptance Criteria (Implied by Argipal's Performance) | Reported Palceram 82SF Performance |
|---|---|---|
| Composition (weight%) | ||
| Palladium (Pd) | 81.5 | 81.6 |
| Tin (Sn) | 14.5 | 14.6 |
| Gallium (Ga) | 3.5 | 3.4 |
| Ruthenium (Ru) | 0.5 | 0.6 |
| Physical & Mechanical Properties | ||
| Melting point range (°C) (solid.) | 1220 | 1220 |
| Melting point range (°C) (liquid) | 1250 | 1250 |
| Hardness (Vickers 5/30) (soft) | 240 | 230 |
| Hardness (Vickers 5/30) (hard) | 245 | 245 |
| Yield strength (MPa) (soft) | 560 | 560 |
| Yield strength (MPa) (hard) | 660 | 660 |
| Elongation (%) (soft) | 15 | 15 |
| Elongation (%) (hard) | 10 | 10 |
| CTE (x10-⁶/°C) | 14.1 | 14.1 |
| Density (g/cm³) | 11.2 | 11.2 |
2. Sample size used for the test set and the data provenance
The document states that "Test methods applied: as in ANSI/ADA 5 and ISO 9693." However, it does not specify the sample size for any of the tests performed or the data provenance (e.g., country of origin, retrospective or prospective). The data presented appears to be summary statistics rather than raw data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns a dental casting alloy, and performance is determined by physical and chemical property testing, not expert interpretation of outputs.
4. Adjudication method for the test set
Not applicable. This submission concerns a dental casting alloy, and performance is determined by physical and chemical property testing, not subjective adjudication.
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 an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The testing described is for material properties.
7. The type of ground truth used
The "ground truth" for the performance claims is based on standard laboratory measurements of chemical composition as well as physical and mechanical properties, conducted according to ANSI/ADA 5 and ISO 9693 standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a training set. The data presented is for the characterization of the material.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of device, this question is not relevant.
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Image /page/0/Picture/0 description: The image shows a logo with the word "AUREX" in a serif font at the bottom. Above the text is a geometric design composed of overlapping triangles. The triangles are filled with solid black, creating a bold and abstract visual element. The logo appears to be a stylized representation of a mountain range or a similar geometric form.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
SEP - 5 1997
KG72956
510 (k) Summary
Trade name: Common name: Classification name: Class ification number:
-20-
PALCERAM 82 SF Dental casting alloy Gold based alloys and precious metal alloys for clinical use EIT
Legally marketed device: Argen Argipal Description of the device: 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 | Pd | Sn | Ga | Ru | |
| Legal | Argipal | 81.5 | 14.5 | 3.5 | 0.5 |
| New | Palceram 82SF | 81.6 | 14.6 | 3.4 | 0.6 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting pointrange (°C) | Hardness(Vickers5/30) | Yieldstrength(MPa) | Elongation(%) | CTE(x10-6/°C ) | Density(g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Name/ | solid. | liquid | soft | hard | soft | hard | soft | hard | |||
| Legal | Argipal | 1220 | 1250 | 240 | 245 | 560 | 660 | 15 | 10 | 14.1 | 11.2 |
| New | Palcefam 82SF | 1220 | 1250 | 230 | 245 | 560 | 660 | 15 | 10 | 14.1 | 11.2 |
Discussion
Practically identical alloys.
FD DAVIS
Submitted by:
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
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
K972956 Re : Palceram 82SF 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 aqainst 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 emroduct Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as inis receir will as on the premarket notification. The FDA acberroom in postantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication wour 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health \
Enclosure
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510(k) Number (if known):_
Device 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)
Suvart Kumar
(Division Sign-6 Division of Dental, Infoction and General Host 5 1 (/k) Number
Prescription Use ) Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.