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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.

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The provided document is an FDA 510(k) clearance letter for a dental bonding agent named "CERARESIN BOND". It declares the device as substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study summary for an AI/ML medical device.

The letter explicitly states: "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)."

This implies that the clearance was based on substantial equivalence to existing devices, not on the presentation of novel performance data from a clinical or analytical study. Therefore, I cannot extract the requested information from this document.

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