K Number

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

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Jelenko Legacy XT

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental casting alloy, a material, and does not mention any software, image processing, or AI/ML terms.

Therapeutic

No
The device is a dental casting alloy used for fabricating restorations, which is a material used in a therapeutic process but is not a device that directly performs therapy.

Diagnostic

No
The device is a dental casting alloy used for fabricating restorations, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "Low gold palladium based casting alloy," which is a physical material, not software.

IVD (In Vitro Diagnostic)

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 or pathological state.
Device Description: The device is described as a "Low gold palladium based casting alloy." This is a material, not a diagnostic test.
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 disease or condition
- Using reagents or other components typically associated with IVD tests

IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental casting alloy does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

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:

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Jelenko Legacy XT

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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 : +27 (11) 609-8640 Telefax : +27 (11) 452-3918

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:

-17-

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.

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:

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 (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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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)

Over-The-Counter Use