PALAUREX 76KF

• K Number: K972953
• Device Name: PALAUREX 76KF
• Manufacturer: AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD
• Date Cleared: 1997-09-05 ( 77 days)
• Product Code: EJT
• Regulation Number: 872.3060
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K012416

Intended Use

Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.

Device Description

Low gold palladium based casting alloy

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Property	Acceptance Criteria (Predicate Device: Legacy XT)	Reported Device Performance (Palaurex 76KF)
Melting point range (solid.)	1190 °C	1115 °C
Melting point range (liquid)	1300 °C	1285 °C
Hardness (Vickers 5/30) - soft	245	220
Hardness (Vickers 5/30) - hard	(Not specified for predicate)	260
Yield strength (MPa) - soft	552	630
Yield strength (MPa) - hard	(Not specified for predicate)	865
Elongation (%) - soft	30	18
Elongation (%) - hard	(Not specified for predicate)	4
CTE (x10-6/°C)	14.3	14.1
Density (g/cm3)	10.8	10.6
Composition (weight%)
Au	2	2
Ag	10	7.5
Pd	75.4	75.6
Sn	0	2.9
In	6	6.2
Ga	6	5.5
Ru	<1	0.3

The "acceptance criteria" here are defined by the properties of the legally marketed predicate device, Jelenko Legacy XT. The study demonstrates that the Palaurex 76 KF, while having some differences, is considered substantially equivalent based on the listed physical and mechanical properties and composition. The discussion indicates that the differences, such as Sn compensating for lower Ag, were deemed acceptable.

2. Sample Size for Test Set and Data Provenance:

   • Sample Size: Not explicitly stated for each test beyond the comparative tables showing single values for each property. The tests were run according to ANSI/ADA 5 and ISO 9693 standards, which would define the number of samples required for each specific test (e.g., hardness, tensile).
   • Data Provenance: Not explicitly stated, but the submission is from "Aurex Precious Metal Industries (PTY) LTD." in the "Republic of South Africa." The data likely originated from their internal testing or accredited labs in support of their submission. The data is retrospective in the context of the 510(k) submission, as it was generated prior to the submission for pre-market notification.

3. Number of Experts and Qualifications:

   • Not applicable. This is a submission for a dental casting alloy, and the evaluation relies on objective physical and chemical property comparisons, not expert interpretation of images or clinical outcomes.

4. Adjudication Method:

   • Not applicable. This is not a study involving human interpretation or clinical adjudication. Properties are measured against standard test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This is a material science comparison, not a study evaluating human readers' performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

   • Not applicable. This is not a software device or an algorithm. The "performance" refers to the intrinsic physical and chemical properties of the alloy.

7. Type of Ground Truth Used:

   • The "ground truth" for the new device's performance is based on measurements taken according to established international standards (ANSI/ADA 5 and ISO 9693).
   • The "ground truth" for the comparison/acceptance criteria is the reported properties of the legally marketed predicate device, Jelenko Legacy XT.

8. Sample Size for Training Set:

   • Not applicable. This is a materials comparison, not a machine learning model.

9. How Ground Truth for Training Set was Established:

   • Not applicable. This pertains to machine learning models, which is not relevant here.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with three overlapping triangles in black. The word "AUREX" is written in a serif font below the triangles. The logo appears to be a stylized representation of mountains or a geometric design. The image is in black and white.

P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : [phone] Telefax : [phone]

SEP - 5 1997

KA72953

510 (k) Summary

PALAUREX 76 KF Trade name: Common name: Dental casting alloy Gold based alloys and precious metal alloys for clinical use Classification name: Class ification number: EJT

Legally marketed device: Jelenko Legacy XT 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:

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ALLOY		COMPOSITION (weight%)
	Name	Au	Ag	Pd	Sn	In	Ga	Ru
Legal	Legacy XT	2	10	75.4	0	6	6	x
New	Palaurex 76 KF	2	7.5	75.6	2.9	6.2	5.5	0.3

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	Legacy XT	1190	1300	245		552		30		14.3	10.8
New	Palaurex 76KF	1115	1285	220	260	630	865	18	4	14.1	10.6

Discussion

There are same element, with the exception of Sn , in both alloys. The Pd, Au, Ga and In content are almost identical. The lower Ag content in Palaurex 76 KF is compensated for by Sn.

Conclusion

The main elements and their concentration are almost identical.

Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07)

Image /page/0/Picture/19 description: The image shows a logo with the text "TÜV CERT" in bold, black letters. The "TÜV" part is larger and placed above "CERT". The logo is enclosed in a rectangular shape with rounded corners and a double-line border. The overall design is simple and professional, likely representing a certification or quality assurance mark.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.

Public Health Service

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

K972953 Re : Palaurex 76KF Trade Name: Requlatory Class: II Product Code: EJT 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 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 320) 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:

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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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A 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):_

PALAUREX Device Name: 76KF

Indications For Use:

1 1

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)

Stuan Runner

(Division Sign-Off) Division of Dental, Infect and General Hospital D 1 1 O(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Regulation Number and Section

§ 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.