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K Number
K981036
Device Name
SMARTBOND
Manufacturer
GAC INTL., INC.
Date Cleared
1999-04-05

(382 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K020648
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

the bonding Adhesive to be used as an orthodontic bonding agent, for the bonding of orthodontic braces on the tooth (brackets, tubes and which ever) for a limited period of time.

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for a device called "Smart-Bond," an orthodontic bonding agent. The provided text is a regulatory document and does not contain information about acceptance criteria, device performance studies, or technical details about the device's efficacy or safety. Therefore, I cannot generate the requested table and study details.

The document only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. It does not include performance data or clinical trial results.

§ 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.