(56 days)
Kerr Corporation, OptiBond Solo Plus 2
Not Found
No
The 510(k) summary describes a dental bonding agent, a chemical product, and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is a bonding agent used in dental procedures, which primarily serves as an adhesive for various dental repairs and restorations. It does not exert any direct therapeutic effect on a disease or condition.
No
Explanation: The device description states it is a multi-purpose bonding agent used for various dental repairs and applications. It does not mention any diagnostic capabilities or functions related to identifying medical conditions.
No
The device description clearly states it is a "multi-purpose bonding agent," 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/Indications for Use: The intended use clearly describes a dental bonding agent used for direct application to tooth structure (enamel and dentin) and various dental restorative materials. This is a direct application to the body or materials used in the body, not for testing samples taken from the body.
- Device Description: The description reinforces its use as a bonding agent for dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.
Product codes
KLE
Device Description
The device is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.
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)
Kerr Corporation, OptiBond Solo Plus 2
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
JUL 2 2003
sds
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-74 84 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: May 2003
Device Name:
- Trade Name OptiBond FL .
- . Common Name - Resin Tooth Bonding Agent
- Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, OptiBond Solo Plus 2 .
Device Description:
The device is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.
Intended Use of the Device:
The intended use of OptiBond FL is for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and for bonding veneers, onlays, and inlays.
Substantial Equivalence:
OptiBond FL is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Kerr Corporation 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 JUL
2003
Kerr Dental Materials Center C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
Re: K031444
Trade/Device Name: Optibond™ FL Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: May 05, 2003 Received: May 08, 2003
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Colleen Boswell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Section I - Indications for Use
Ver/ 3 - 4/24/96 Applicant: Kerr Dental Material Center 510(k) Number (if known): Device Name: OptiBond FL Indications For Use: OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays. Division of Anesthesiology, General Ho ction Control. Dental De (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)