(67 days)
Not Found
No
The 510(k) summary describes a dental casting alloy and its physical/mechanical properties, with no mention of AI or ML.
No
The device is described as "Dental casting alloy for making dental restorations and appliances," indicating it is a material used for fabrication rather than a device with a direct therapeutic effect on the body.
No
Explanation: The device is described as a "Dental casting alloy for making dental restorations and appliances," specifically a "High gold casting alloy." Its intended use is for creating physical dental structures, not for diagnosing medical conditions. The performance studies focus on material properties like melting point, hardness, and strength, which are relevant to a manufacturing material, not a diagnostic tool.
No
The device is a dental casting alloy, which is a physical material used to create dental restorations. The description and performance studies focus on the material's composition and physical properties, not software functionality.
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 for making dental restorations and appliances." This describes a material used to create physical structures within the mouth, not a test performed on a biological sample to diagnose a condition.
- Device Description: It's described as a "High gold casting alloy," which is a material, not a diagnostic test.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to be 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 for making dental restorations and appliances.
Product codes
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
Comparison of composition:
ALLOY, COMPOSITION (weight%)
Name, Au, Ag, Pt, Pd, Cu, Zn, In, Ir
Legal, Sturdicast, 60, 22, 0, 3.8, 14, 0, x, x
New, AurecastBio59PF, 58.9, 23, 4.1, 0, 12.3, 1.5, 0, 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 (%), Density (g/cm3)
Name, solid., liquid, soft, hard, soft, hard, soft, hard,
Legal Sturdicast, 860, 905, 175, 270, 352, 703, 40, 8, 14.1
New Aurecast, 858, 884, 205, 270, 345, 520, 19, 6, 14.2
Bio59PF
Discussion: The noble metal content of the two alloys differs very little (2%). The (Ag+Cu) content is also very close. Aurecast Bio59PF uses Zn as deoxidizing agent. Physical and mechanical properties shoe only little difference.
Key Metrics
Not Found
Predicate Device(s)
Jelenko Sturdicast
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
AUG 2 S
Image /page/0/Picture/2 description: The image shows a logo for AUREX. The logo consists of two overlapping triangles, with the word "AUREX" written below them. There is a line underneath the word AUREX. The triangles and text are black, and the background is white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
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510 (k) Summary
| Trade name: | AURECAST BIO 59 PF |
|---|---|
| Common name: | Dental casting alloy |
| Classification name: | Gold based alloys and precious metal alloys for clinical use |
| Class ification number:EJT |
Legally marketed device: Jelenko Sturdicast Description of the device: High gold casting alloy Intended use of the device: Type IV restorations
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 and ISO 8891
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Pd | Cu | Zn | In | Ir | |
| Legal | Sturdicast | 60 | 22 | 0 | 3.8 | 14 | 0 | x | x |
| New | AurecastBio59PF | 58.9 | 23 | 4.1 | 0 | 12.3 | 1.5 | 0 | 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 (%) | Density (g/cm3) | ||||
|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | |
| Legal Sturdicast | 860 | 905 | 175 | 270 | 352 | 703 | 40 | 8 | 14.1 |
| New Aurecast | 858 | 884 | 205 | 270 | 345 | 520 | 19 | 6 | 14.2 |
| Bio59PF |
Discussion
The noble metal content of the two alloys differs very little (2%). The (Ag+Cu) content is also very close. Aurecast Bio59PF uses Zn as deoxidizing agent. Physical and mechanical properties shoe only little difference.
Conclusion
With the exception of a very small amount of Zn and In the two alloys have similar constitution and mechanical characteristics. It may be assumed that the corrosion and tamish resistance and the biological effect do not differ substantially.
==
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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 entwined around it. Above the caduceus, the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) LTD P.O. Box 509 Edenvale 1610 Republic of South Africa
Re: K972939 Aurecast Bio 59PF 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ಕ್ಕೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as sec 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: this response to your premarket notification submission does not affect any obligation you might 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 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 diaqnostic 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 qeneral 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.ffla.gov/cdrh/dsmamain.html".
Sincerely yours,
Alidatist
Timo A Director 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):_____________________________________________________________________________________________________________________________________________________
'evice Name: AURECAST BIO 59PF
Indications For Use:
Dental casting alloy for making dental restorations and appliances.
SE WITH DENTAL PORCELAINS NI (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruma
(Division Sign-Off Division of Dental, it and General Hos 510(k) Number
escription Use
(21 CFR 801.109)
Over-The-Counter Use