TRANSBOND SUPREME ADHESIVE

K073697 · 3M Unitek · DYH · Feb 15, 2008 · Dental

Device Facts

Record IDK073697
Device NameTRANSBOND SUPREME ADHESIVE
Applicant3M Unitek
Product CodeDYH · Dental
Decision DateFeb 15, 2008
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3750
Device ClassClass 2

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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