(83 days)
Not Found
Not Found
No
The summary describes a dental alloy, a material, and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a "NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS," which are dental restorative materials, not devices intended for therapy.
No
Explanation: The device is described as a non-precious metal alloy for dental restorations (veneers, crowns, bridges, inlays, onlays), which are used for treatment and not for diagnosing a condition.
No
The device description clearly states it is a "Non-Precious Metal 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 for creating dental restorations (veneers, crowns, bridges, inlays, onlays). This is a structural and restorative application, not a diagnostic one.
- Device Description: The device is a non-precious metal alloy. This is a material used in manufacturing, not a diagnostic test or reagent.
- Lack of Diagnostic Information: There is no mention of analyzing samples from the human body, detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This metal alloy does not fit that description.
N/A
Intended Use / Indications for Use
NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.
Product codes
EJH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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 the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anna Chin Distributor C.K. International Trading 2807 Holly Avenue Arcadia, California 91007
DEC I I 1997
Re : K973568 Trade Name: Sowell Nickel-Chrome Non-Precious Metal Alloy Regulatory Class: II Product Code: EJH Dated: September 16, 1997 September 19, 1997 Received:
Dear Ms. Chin:
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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of
1
Page 2 - Ms. Chin
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 (301) 594-4692. 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.gow/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
K973568 510(k) Number (if known):
NICKEL-CHROME NON-PRECIOUS METAL ALLOY Device Name:
.. |
Indications For Use: NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices પ્ર 510(k) Number _ 56
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)