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K Number
K110252
Device Name
BEAUTIBOND MULTI PR PLUS
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2011-05-13

(105 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 PR Plus is dental adhesive to ceramic, consisting primarily of surface treatment material (silane coupling agent). This product is intended for bonding composite resin to ceramics other than alumina and zirconia or composite resin to repair fractured restorations or prostheses.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental bonding agent, BeautiBond Multi PR Plus. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it is a regulatory approval document and not a scientific study report.

Therefore, I cannot extract the requested information from this document.

§ 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.