(77 days)
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No
The summary describes a dental casting alloy and its physical properties, with no mention of AI or ML.
No
This device is a dental casting alloy used for restoration, not a therapeutic device meant to treat or cure a disease or condition.
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 for creating dental restorations, not a tool for diagnosing medical conditions.
No
The device is a dental 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 for fabricating dental restorations, which is a clinical application within the mouth, not a diagnostic test performed on samples taken from the body.
- Device Description: It's a casting alloy, a material used in the manufacturing process of a dental device.
- Lack of IVD Characteristics: The description lacks any mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental casting alloy does not fit that definition.
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 based 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
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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)
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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.
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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 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 | 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:
Image /page/0/Picture/17 description: The image shows the date "17 June 1997" in a simple, sans-serif font. The numbers and letters are clear and legible against a white background. The date is written in a standard format, with the day of the month followed by the month and then the year. The text is horizontally aligned and evenly spaced.
Image /page/0/Picture/19 description: The image shows a logo with the text "TUV CERT" in a stylized font. The "TUV" part is larger and bolder than the "CERT" part, which is placed directly below it. The logo is enclosed within a rounded rectangular border, and there are two curved lines above the text, adding a sense of design and structure to the overall image. The logo appears to be a certification mark, possibly indicating that a product or service has met certain standards.
1
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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
2
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
3
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