Search Results
Found 2 results
510(k) Data Aggregation
K Number
K181604Device Name
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
Manufacturer
Date Cleared
2018-11-28
(162 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
HRS Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
to obtain the structure of a patient's teeth and gums
Device Description
Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of whatever surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.
To create the material, the user simply mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and slightly modified, it is taken to patient's mouth for use in the transfer bonding process.
Ask a Question
Ask a specific question about this device
K Number
K132869Device Name
SILDENT
Manufacturer
Date Cleared
2014-06-19
(279 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
HRS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
Device Description
The Sildent is a vinyl polysiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.
The Sildent consists of 4 type models. These are Sildent light body, Sildent regular body, Sildent heavy body and Sildent putty.
Ask a Question
Ask a specific question about this device
Page 1 of 1