(39 days)
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Not Found
No
The 510(k) summary describes a dental adhesive and contains no mention of AI or ML technology.
No
The device is described as an adhesive bond for dental tissue and restorative materials, which is not a therapeutic function.
No
The device is described as an adhesive bond for dental tissue and restorative materials, which is a therapeutic function, not a diagnostic one.
No
The intended use describes a physical adhesive bond, which is a material, not software. The summary provides no information suggesting a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to bond dental tissue to restorative materials. This is a direct application within the body (or on a part of the body, the teeth) for a therapeutic or restorative purpose.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health or condition. The description of Solobond M does not involve any such examination of specimens.
Therefore, Solobond M is a dental material used for bonding, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Solobond M is intended for use as an adhesive bond between hard dental tissue (dentin / enamel) and light-curing restorative materials.
Product codes
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
hard dental tissue (dentin / enamel)
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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
VOCO GmbH C/O Evan G. Dick, Ph.D. E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re : K980539 Solobond M Trade Name: Regulatory Class: II Product Code: KLE Dated: February 12, 1998 February 12, 1998 Received:
Dear Dr. Dick:
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 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
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Page 2 - Dr. Dick
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 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 x/A. Directo 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 STATEMENT
510(k) Number (if known): K980539
Device Name: Solobond M
Indications For Use:
Solobond M is intended for use as an adhesive bond between hard dental tissue (dentin / enamel) and light-curing restorative materials.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980539 |
| Prescription Use
| (per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------------------------------ | ---------------------------------------------------------------- | ---- | ---------------------- | -- |