(67 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
This device is a dental casting alloy used for making restorations and appliances, which are passive components and not directly involved in treating or alleviating a disease or condition. Therefore, it is not considered a therapeutic device.
No
Explanation: The device is described as a "Dental casting alloy for making dental restorations and appliances," which indicates it is a material used in the creation of dental prosthetics, not a tool for diagnosing conditions.
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 for making dental restorations and appliances." This describes a material used to create physical structures for dental purposes.
- Device Description: The device is described as a "High gold casting alloy." This further reinforces its nature as a material for fabrication.
- Lack of IVD Characteristics: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with human specimens or diagnostic testing.
- Performance Studies: The performance studies focus on comparing the composition and physical/mechanical properties to a predicate device, which is typical for materials used in manufacturing. They do not involve clinical or diagnostic performance metrics.
Therefore, this device falls under the category of a dental material used for fabrication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental casting alloy for making dental restorations and appliances.
FOR USE WITH DENTAL PORCELAIN NOT (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division ! 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use ------
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:
ALLOY Name COMPOSITION (weight%) Au Ag Pt Cu Zn In Ir
Legal Benchmark IV 70 12 5 12.5 0 x x
New Aurecastbio69PF 69.7 14 3.8 10.8 1.4 0 0.3
x is less than 1 %
Comparison of physical and mechanical properties
ALLOY Name Melting point range (°C) Hardness (Vickers 5/30) Yield strength (MPa) Elongation (%) Density (g/cm3)
solid. liquid soft hard soft hard soft hard
Legal Benchmark IV 890 930 195 285 352 670 40 9 15.5
New Aurecast Bio60PE 878 905 180 250 320 485 30 6 15.3
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 Benchmark IV
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 for "AUREX". The logo consists of three overlapping triangles, forming a complex geometric shape. The word "AUREX" is printed in bold, uppercase letters below the geometric shape. The logo appears to be in black and white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
AUG 26 1997
510 (k) Summary
AURECAST BIO 69 PF Trade name: Dental casting alloy Common name: Gold based alloys and precious metal alloys for clinical use Classification name: EJT Class ification number:
Legally marketed device: Jelenko Benchmark IV 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:
-6-
| ALLOY | COMPOSITION (weight%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Cu | Zn | In | Ir | ||
| Legal | Benchmark IV | 70 | 12 | 5 | 12.5 | 0 | x | x | |
| New | Aurecastbio69PF | 69.7 | 14 | 3.8 | 10.8 | 1.4 | 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 | Benchmark IV | 890 | 930 | 195 | 285 | 352 | 670 | 40 | 9 | 15.5 |
| New | Aurecast | 878 | 905 | 180 | 250 | 320 | 485 | 30 | 6 | 15.3 |
| | Bio60PE | | | | | | | | | |
Discussion
The major constituents up to 98% are the same. The same within 0.1%. Both alloys are built up from the same elements save a small amount of indium, which cannot cause any considerable difference.
Conclusion
Due to the similarity of the constitution it may be assumed that the chemical behaviour and the biological effect should be quite similar
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the 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
AUG 26 1597
Re: K972940 Trade Name: Aurecast Bio 69PF Requlatory Class: II EJT Product Code: 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 Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) ior 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 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 W. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K972940 510(k) Number (if known): __
Device Name: AURECAST BIO 69PF
Indications For Use:
:
ప్లిప్ల
Dental casting alloy for making dental restorations and appliances.
FOR USE WITH DENTAL PORCELAIN NOT (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suar Purari
Division ! 510(k) Number
Prescription Use
er 21 CFR 801.109)
OR
Over-The-Counter Use ------