(83 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use describes traditional dental prosthetics.
No
The provided information describes a device for dental applications (partials, stayplates, clasps, and rests), which are generally considered prosthetic or restorative, not therapeutic. There is no indication of treating or preventing a disease or condition.
No
The provided "Intended Use" describes the function of a dental prosthetic or orthodontic component (partials, stayplates, clasps, rest) rather than a device used to identify a condition or disease.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use "FOR PARTIALS, STAYPLATES, CLASPS AND REST ON MISSIAL OR BISTAL" describes a device used in dentistry for creating or modifying dental prosthetics. This is a mechanical or structural application, not a diagnostic one.
- Lack of Diagnostic Information: IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information gives no indication of this type of use.
- Missing Information: The lack of information in sections like "Device Description," "Input Imaging Modality," "Anatomical Site," and performance study details further supports that this is not a diagnostic device. IVDs typically involve analyzing biological samples or images for diagnostic purposes.
In summary, the intended use clearly points to a dental prosthetic or related device, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
FOR PARTIALS, STAYPLATES, CLASPS AND REST ON MISSIAL OR DISTAL.
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
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
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 features a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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 1 1 1997
Re : K973567 Trade Name: Sowell Cobalt-Chrome Metal Alloy Regulatory Class: II Product Code: EJH September 16, 1997 Dated: Received: September 19, 1997
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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ 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 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 might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directo
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page I of of -
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
COBALT-CHROME HETAL ALLOY Device Name:
FOR PARTIALS, STAYPLATES, CLASPS AND REST ON Indications For Use: MISSIAL OR BISTAL.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suann Plunn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 11735
Prescription Use V (Per 21 CFR 801.109)
ાવ
Over-The-Counter Use_
(Optional Format 1-2-96)