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K Number
K110235
Device Name
BEAUTIBOND MULTI
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2011-05-13

(107 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided document is an FDA 510(k) clearance letter for a dental bonding agent (BeautiBond Multi). It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for. This information (like sample sizes, expert qualifications, adjudication methods, ground truth, etc.) would typically be found in the actual 510(k) submission summary or a scientific publication related to the device.

Therefore, I cannot provide the requested table and study details based on the given text.

§ 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.