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K Number
K143667
Device Name
GC KommonBase
Manufacturer
GC Orthodontics America Inc.
Date Cleared
2015-05-07

(135 days)

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

Fabricating resin base (understructure) for bracket placement

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "GC KommonBase." This letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria, study details, or performance data for the GC KommonBase device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance studies.

§ 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.