LogoFDA 510(k) Search
K Number
K001446
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
Reference & Predicate Devices
N/A
Predicate For
K202276
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 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.