(19 days)
KLE
Not Found
No
The document describes a dental bonding agent and does not mention any AI or ML components or functionalities.
No
The device is a bonding agent used for dental procedures, which is a restorative material, not a therapeutic agent that treats or prevents a disease.
No
Explanation: The device description clearly states its purpose is as a "multi-purpose bonding agent" for various dental restorations and repairs (e.g., composite to enamel, crowns, bridges, post cementation). This functionality is therapeutic or restorative, not diagnostic. A diagnostic device is used to identify or detect a disease or condition.
No
The device description clearly states it is a "multi-purpose bonding agent," which is a physical substance (a chemical compound) used in dentistry, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a "multi-purpose bonding agent" used for various dental procedures involving bonding materials to tooth structure (enamel and dentin) and other dental materials. This is a direct application within the body (or on materials that will be placed in the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces its use as a bonding agent for dental applications, both direct and indirect.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of such samples.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples. This device is a material used directly in a dental procedure.
N/A
Intended Use / Indications for Use
The intended use of OptiBond Solo Plus is for bonding in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, Maryland bridges, post cementation.
Product codes
KLE
Device Description
The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding and bonding composite core build-up materials. Additionally, because the device contains a dual cure catalyst, OptiBond Solo Plus can be used for indirect situations as well including veneers, onlays, inlays, crowns, Maryland bridges and post cementation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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)
Dentsply International, Prime & Bond 2.1
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/0 description: The image contains the logo for Sybron Dental Specialties, along with the text "Section III - 510(k) Summary of Safety and Effectiveness". There is also a handwritten number "199" in the top left corner and "K990498" on the right side of the logo. The logo features the letters "sds" in a stylized font.
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared:
February 1999
Device Name:
- Trade Name OptiBond Solo Plus ●
- Common Name Bonding Agent ●
- Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .
Devices for Which Substantial Equivalence is Claimed:
- . Dentsply International, Prime & Bond 2.1
Device Description:
The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding and bonding composite core build-up materials. Additionally, because the device contains a dual cure catalyst, OptiBond Solo Plus can be used for indirect situations as well including veneers, onlays, inlays, crowns, Maryland bridges and post cementation.
Intended Use of the Device:
The intended use of OptiBond Solo Plus is for bonding in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, Maryland bridges, post cementation.
Substantial Equivalence:
OptiBond Solo Plus is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Dentsply International functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 1999
Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
K990498 Re : Optibond Solo Plus Trade Name: Regulatory Class: II Product Code: KLE February 16, 1999 Dated: Received: February 17, 1999
Dear Ms. Boswell:
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 abe Beated in the enough 3, 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. ਸ 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Boswell
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets probles, 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 che Office or Compiland, "Misbranding by reference to the regulation entification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information of your be 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
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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Section I - Indications for Use
510(k) Number:
Device Name: OptiBond Solo Plus
Indications for Use:
OptiBond Solo Plus is a multi-purpose bonding agent designed to be used in direct Optibolia Solo Frus is a manel and/or dentin, composite repair, porcelain repair, Situations, I.C., composite to enailer ag, bonding composite core build-up materials, and composite to mount, analgain commons, inlays, crowns, Maryland bridges, post cementation.
●
Susan Roaser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1299 098 510(k) Number.