(63 days)
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No
The summary describes a dental cement and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No.
The device is described as an orthodontic adhesive for bonding dental appliances, which is a structural or supportive function rather than a therapeutic one (e.g., treating a disease or condition).
No
The device description states it is a dental cement, not a tool for diagnosis. Its intended use is for bonding orthodontic appliances, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "glass ionomer dental cement," 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 "as an orthodontic adhesive for brackets, bands and bonded appliances." This describes a material used in the body for a structural purpose, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "glass ionomer dental cement." This is a material used in dentistry for bonding and filling, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (substances in the body)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, GC Fuji Ortho LC is a medical device, but it falls under the category of a dental material used for bonding, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.
Product codes
DYH
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three curved lines representing the eagle's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
Ms. Terry L. Joritz Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Chicago, Illinois 60658
Re: K981461 GC Fuji Ortho LC Trade Name: Requlatory Class: II Product Code: DYH Dated: April 22, 1998
Received: April 23, 1998
Dear Ms. Joritz:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ನ್ನ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Ms. Joritz
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 markets 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
Timot AA. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Device Name: GC FUJI ORTHO LC Modified
Indications For Use: GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.
Herald Sheppard
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
: