(182 days)
Jelenko Jel 96
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of AI, ML, image processing, or any software-based functionality.
No
A therapeutic device is one that treats or alleviates a disease or condition. This device is a dental casting alloy used to fabricate restorations, which is a restorative material, not a therapeutic agent.
No
The device is a dental casting alloy used for restoration fabrication, not for diagnosing medical conditions.
No
The device description clearly states it is a "High gold 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 mouth for creating dental prosthetics.
- Device Description: It's described as a "High gold casting alloy." This is a material used in the manufacturing process of a dental device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a person's health status, diagnosis, or disease.
- Being used in a laboratory setting for testing.
IVDs are devices 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 description.
N/A
Intended Use / Indications for Use
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
High gold 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 and mechanical properties between the new device (Aurelux 77) and the legally marketed predicate device (Jelenko Jel 96). The key results indicate that the two alloys have almost identical composition and properties, with a noble metal content higher than 95% in both, and less than 1% difference in base metal concentration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Jelenko Jel 96
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.
Not Found
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).
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
Image /page/0/Picture/1 description: The image shows a logo with the word "AUREX" in bold, capitalized letters. Above the word is a black geometric shape that resembles two overlapping triangles or mountains. A horizontal line underlines the word "AUREX", emphasizing the brand name.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
AURELUX 77 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 Jel 96 Description of the device: High gold casting alloy Intended use of the device: Type IV restorations 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 | Au | Ag | Pt | Pd | Cu | Fe | Sn | In | Ir | |
| Legal | Jel 96 | 78 | 1.2 | 6 | 12 | 4.5 | 1 | x | x | x |
| New | Aurelux 77 | 76.6 | 1.2 | 9.9 | 9.3 | 0.5 | 0.2 | 0.6 | .1.5 | 0. |
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 Jel 96 | 1170 | 1260 | 255 | 655 | 4 | 14.5 | 17.2 | |||
| New Aurelux 77 | 1150 | 1230 | 200 | 245 | 350 | 650 | 19 | 11 | 14.1 | 18.5 |
Discussion
With the exception of a very small copper content the two alloys have almost identical composition and properties. The noble metal content in both alloys is higher than 95 %. Less than 1 % difference in base metal concentration.
Conclusion
The major constituent (Au) and the noble metal content are similar. Even the residuals are the same elements.
The very high noble metal content suggest an effective biocompatibility
Image /page/0/Picture/22 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rectangular box with rounded corners. There are two curved lines above the text, and the text "ISO 9001" is below the text.
-11-
1
:
DEC 1 9 1997
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
K972946 Re : Trade Name: Aurelux 77 Requlatory Class: II Product Code: EJT October 6, 1997 Dated: Received: October 17, 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 reqistration, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531
2
Page 2 - Mr. Davis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/1 description: The image shows a logo with the word "AUREX" in bold, capitalized letters. Above the word is a black geometric shape that resembles two overlapping triangles or mountains. A horizontal line underlines the word "AUREX", emphasizing the brand name.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
AURELUX 77 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 Jel 96 Description of the device: High gold casting alloy Intended use of the device: Type IV restorations 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 | Au | Ag | Pt | Pd | Cu | Fe | Sn | In | Ir | |
| Legal | Jel 96 | 78 | 1.2 | 6 | 12 | 4.5 | 1 | x | x | x |
| New | Aurelux 77 | 76.6 | 1.2 | 9.9 | 9.3 | 0.5 | 0.2 | 0.6 | .1.5 | 0. |
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 Jel 96 | 1170 | 1260 | 255 | 655 | 4 | 14.5 | 17.2 | |||
| New Aurelux 77 | 1150 | 1230 | 200 | 245 | 350 | 650 | 19 | 11 | 14.1 | 18.5 |
Discussion
With the exception of a very small copper content the two alloys have almost identical composition and properties. The noble metal content in both alloys is higher than 95 %. Less than 1 % difference in base metal concentration.
Conclusion
The major constituent (Au) and the noble metal content are similar. Even the residuals are the same elements.
The very high noble metal content suggest an effective biocompatibility
Image /page/3/Picture/22 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rectangular box with rounded corners. There are two curved lines above the text, and the text "ISO 9001" is below the text.
-11-
4
:
DEC 1 9 1997
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
K972946 Re : Trade Name: Aurelux 77 Requlatory Class: II Product Code: EJT October 6, 1997 Dated: Received: October 17, 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 reqistration, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531
5
Page 2 - Mr. Davis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ 77
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)
Susan Runoe
(Division Sign-Off) Division of Den and General H 510(k) Numb
Prescription Use `er 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)