PALAUREX 76KF

K972953 · Aurex Precious Metal Industries (Pty)Ltd · EJT · Sep 5, 1997 · Dental

Device Facts

• Record ID: K972953
• Device Name: PALAUREX 76KF
• Applicant: Aurex Precious Metal Industries (Pty)Ltd
• Product Code: EJT · Dental
• Decision Date: Sep 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

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

Device Story

Palaurex 76 KF is a low gold palladium-based dental casting alloy. It is used by dental professionals for the fabrication of metallo-ceramic restorations. The alloy is designed to be combined with dental ceramics to create durable dental prosthetics. It functions as a structural material for dental crowns or bridges. The device is intended for prescription use only.

Clinical Evidence

Bench testing only. Performance evaluated via physical and mechanical property testing, including melting point range, Vickers hardness, yield strength, elongation, and coefficient of thermal expansion (CTE), compared against the predicate device. Testing conducted in accordance with ANSI/ADA 5 and ISO 9693 standards.

Technological Characteristics

Low gold palladium-based casting alloy. Composition: Au (2%), Ag (7.5%), Pd (75.6%), Sn (2.9%), In (6.2%), Ga (5.5%), Ru (0.3%). Physical properties: Melting point 1115-1285°C; Vickers hardness 220-260; Yield strength 630-865 MPa; CTE 14.1 x 10^-6/°C. Tested per ANSI/ADA 5 and ISO 9693.

Indications for Use

Indicated for use in dental patients requiring metallo-ceramic restorations, specifically for the fabrication of Type IV restorations with porcelain veneering.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Jelenko Legacy XT

Submission Summary (Full Text)

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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)

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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:

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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