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510(k) Data Aggregation
K Number
K132599Device Name
SMILEBOND SYSTEM
Manufacturer
Date Cleared
2014-02-25
(189 days)
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
MILLENNIUM COMPANY LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SmileBond Systems Fast Bite Registration material is used for making impressions of the tech and gums of patients requiring enhancement of the smile and for bite alignment.
Device Description
SmileBond System is a patented process for the delivery of dental bonding composites. The SmileBond process is indicated for both cosmetic enhancement of the smile, and functional improvement of the bite (or chewing system).
Fast-Set Bite Registration is a silicone impression material intended to be placed on an impression tray to reproduce the structures of the teeth and gums of patients requiring the enhancement of the smile and for bite alignment. The impression material is intended to be applied via a dual barrel cartridge system into an impression tray. The clear impression material is used in the lab to make an accurate impression of the final wax up. Once the impression material is set and slightly modified it is taken to the mouth for use in the transfer bonding process.
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