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K Number
K050750
Device Name
LC BRACKET ADHESIVE SYSTEM
Manufacturer
DENTSPLY INTL.
Date Cleared
2005-04-06

(14 days)

Product Code
DYH
Regulation Number
872.3750
Type
Special
Panel
DE
Reference & Predicate Devices
K033703
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonding of orthodontic brackets to natural and artificial tooth surfaces

Device Description

The LC BRACKET ADHESIVE SYSTEM is a two-part lightcure system (adhesive and primer) used in conjunction with a tooth conditioner.

AI/ML Overview

The provided text is a 510(k) summary for the DENTSPLY International LC BRACKET ADHESIVE SYSTEM. It describes the device, its intended use, and states that it relies on substantial equivalence to predicate devices because its components have been used in legally marketed devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory filing stating substantial equivalence, not a study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.