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K Number
K001446

Validate with FDA (Live)

Device Name
LIGHT-CURED ORTHODONTIC BAND CEMENT
Manufacturer
SCIENTIFIC PHARMACEUTICALS, INC.
Date Cleared
2000-07-21

(74 days)

Product Code
DYH
Regulation Number
872.3750
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K202276
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.