LogoFDA 510(k) Search
K Number
K031420
Device Name
S & C -BRACKET ADHESIVES
Manufacturer
S & C POLYMER GMBH
Date Cleared
2003-08-20

(107 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
  1. Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets.
  2. Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets.
  3. One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.
Device Description

Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets. Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for S & C Polymer's Bracket Adhesives, detailing contact information, device names, descriptions, intended use, and claims of substantial equivalence to predicate devices. It also includes the FDA's clearance letter acknowledging substantial equivalence.

Therefore, I cannot provide the requested table and study details.

§ 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.