(46 days)
Not Found
Not Found
No
The summary describes a dental material for bonding, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics associated with AI/ML algorithms.
No
The device is described as a "metal surface treatment material" used for bonding in dental appliances, not for treating a disease or condition.
No.
The device description and intended use indicate that Metalprimer II is a material for surface treatment and bonding in dental appliances, not for diagnosing medical conditions.
No
The device description clearly states it is a "metal surface treatment material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material used for bonding resin to metal in the fabrication and repair of dental appliances. This is a material used in the creation and maintenance of medical devices, not for testing samples taken from the human body to diagnose or monitor a medical condition.
- Device Description: The description reinforces that it's a "metal surface treatment material."
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
Therefore, Metalprimer II falls under the category of a dental material used in the fabrication of medical devices, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Metalprimer II is a metal surface treatment material which provides a bond between the resin and metal in fabriacting dental appliances such as bonding opaque material to metal framework for hard resin veneer crowns, bonding denture base resin to metal base, clasp, attachment, repair of denture and bonding orthodontic resin to metal orthodontic bracket and wire.
Product codes (comma separated list FDA assigned to the subject device)
KLE
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.
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).
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§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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 with three heads, representing the department's commitment to health, human services, and science. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the upper portion of the circle, emphasizing the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry L. Joritz Director - Regulatory Affairs & Quality Control GC America, Incorporated ... 3737 W. 127th Street Chicago, Illinois 60658
AUG 26 1997
K972594 Re : Metalprimer II Trade Name: Requlatory Class: II Product Code: KLE Dated: July 7, 1997 Received: July 11, 1997
Dear Mr. 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 reqistration, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set 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 In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Joritz --
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 requlation 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
Timothv A Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
(-16(k) # K972594
Device Name:
Metalprimer II
Indications for Use:
Metalprimer II is a metal surface treatment material which provides a bond between the resin and metal in fabriacting dental appliances such as bonding opaque material to metal framework for hard resin veneer crowns, bonding denture base resin to metal base, clasp, attachment, repair of denture and bonding orthodontic resin to metal orthodontic bracket and wire.
Concurrence of CDRH/ODE
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dey 510(k) Number .
Prescription use Yes
ves the County use No