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510(k) Data Aggregation
K Number
K091533Device Name
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
Manufacturer
Date Cleared
2009-08-17
(83 days)
Product Code
Regulation Number
872.4565Why did this record match?
Product Code :
JEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.
Device Description
Matrix bands are used to retain composite and other restorative materials during dental restorations. In general a matrix band surrounds the tooth and is used to separate the teeth while a composite filling is placed. The type of band is selected based on the tooth height and restoration type. The dentist prepares the tooth and places the band on the tooth. A wedge is inserted for optimal contour, gingival seal, and tooth separation. A ring retainer such as the Composi-Tight 3D Ring or Composi-Tight 3D Thin Tine G Ring is used to hold the band in place. The band is removed after the application of composite resin. The devices are offered in different thicknesses, lengths, and widths to accommodate different sized teeth. Additionally, the device is offered in soft stainless steel and hard stainless steel depending on the preference of the dentist. The devices are offered in sectional matrix style or standard style (Tofflemire style). The Tofflemire style is a longer thinner band with or without lobes. The choice of style is dependent on the preference of the dentist and the specific condition and size of the patient's teeth.
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