(56 days)
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Not Found
No
The 510(k) summary describes a dental bonding system and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a bonding system used for dental repairs, not for preventing, diagnosing, or treating a disease or condition.
No
The provided text describes a light-curing bonding system used for repairing dental restorations and prostheses. Its purpose is to bond materials, not to diagnose medical conditions or diseases.
No
The intended use describes a "light-curing bonding system" and mentions "composite resin," which are physical materials and processes, not software. The lack of a device description further supports that this is not a software-only device.
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 bonding system for repairing dental restorations and prostheses. This is a direct application to materials used in the mouth, not a test performed on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
The device is a material used in dental procedures for repair, which falls under the category of a dental restorative or repair material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CERARESIN BOND is a light-curing bonding system for intraoral and extraoral repairs of dental ceramic and resin restorations or prostheses (facing crowns, veneers and implant superstructures) as well as artificial teeth (porcelain, hard resin and acrylic resin teeth) using direct/indirect composite resin.
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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 28, 2012
Mr. David P. Morais Operations Manager, QMR Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078
Re: K123119
Trade/Device Name: Ceraresin Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 25, 2012. Received: October 3, 2012
Dear Mr. Morais:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.
1
Page 2 - Mr. Morais
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
2012.11.28 Susan Runner DDS, MA -05-25:37 -05'00'
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Indications for Use
Kl.23119
510(k) Number (if known):
Device Name: CERARESIN BOND
Indications For Use:
CERARESIN BOND is a light-curing bonding system for intraoral and extraoral repairs of dental ceramic and resin restorations or prostheses (facing crowns, veneers and implant superstructures) as well as artificial teeth (porcelain, hard resin and acrylic resin teeth) using direct/indirect composite resin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODGD2.11.28 Device Evaluation (ODS, MAS 12:12:42 -055'00'
12:12:42 -05'00'
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Shofu Dental Corporation CERARESIN BOND 510(k) Premarket Notification İX