(77 days)
Not Found
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of AI or ML.
No
The device is a dental casting alloy used for fabricating restorations, which is a material used in treatment rather than a device that directly performs a therapeutic function itself.
No
The device is a dental casting alloy used for restoration, not for diagnosing medical conditions. It's a material used in treatment, not a tool for identification or assessment.
No
The device is a dental casting alloy, which is a physical material, not software.
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 diagnostic information.
- Device Description: The device is described as a "Medium gold palladium based casting alloy." This is a material used in manufacturing, not a diagnostic test kit or instrument.
- 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, condition, or physiological state.
- Reagents, calibrators, controls, or other components typically associated with IVDs.
The information provided clearly indicates this is a dental material used for restorative purposes, which falls under a different regulatory category than IVDs.
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
Medium 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 and physical/mechanical properties to a legally marketed device (Jelenko Cameo). Key results showed differences in concentration for every component are less than 5% and elements under 1% content have little effect upon the characteristics. Up to 99% both alloys consist of the same elements, suggesting similar chemical and biological behavior.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Jelenko Cameo
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP - 5 1997
Image /page/0/Picture/1 description: The image shows a logo for AUREX. The logo consists of a geometric shape above the word "AUREX". The geometric shape appears to be made of three overlapping triangles, creating an abstract design. The logo is black and white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
-15-
17295
510 (k) Summary
Trade name: Common name: Classification name: Class ification number: HIPALLAUR 51 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT
Legally marketed device: Jelenko Cameo Description of the device: Medium 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 ANSVADA 5 and ISO 9693
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Pd | Sn | In | Fe | Mn | Re | Ir | Ru | |
| Legal | Cameo | 52.5 | 16 | 0 | 27 | 2 | 2.5 | 0 | x | x | x | 0 |
| New | Hipallaur 51 | 50.6 | 17.6 | 0.2 | 26.5 | 2.1 | 2 | 0.3 | 0.5 | 0.1 | 0 | 0.1 |
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 | Cameo | 1200 | 1280 | 240 | 448 | 12 | 14.9 | 14.1 | |||
| New | Hipallaur 51 | 1220 | 1240 | 250 | 265 | 560 | 630 | 5 | 3 | 14.5 | 14.1 |
Discussion
All the elements above 1 % are the same in both alloys. The difference in concentration for every component is less than 5 %. The elements under 1 % content are either noble ones, or the ones that oxidize and be eliminated during melting. Consequently, they have little effect upon the characteristics of the alloys.
Conclusion
Up to 99 % both alloy consist of the same elements. This suggets that chemical and biological behaviour should be similar.
Image /page/0/Picture/21 description: The image shows a logo with the letters "TUV" in bold, black font. Above the letters are two small squares. The logo is enclosed in a rounded rectangular shape with a double border. The logo appears to be a certification mark.
1
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
Re : K972951 Hipallaur 51 Trade Name: Regulatory 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 The general controls provisions of the Act 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 Requlations, 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 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
2
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 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 one 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
K. Matust
Timothy A. Ulatowski Diredtor 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: HIPALLAUR 51
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)
S. Vanover
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use