Search Results
Found 2 results
510(k) Data Aggregation
K Number
K123824Device Name
VITRO FIL LC
Manufacturer
Date Cleared
2013-02-21
(71 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DFL INDUSTRIA E COMERCIO S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations
- Restoration of root surface caries
- Restorations of cervical erosions
- Small Class I restorations
- Primary teeth restoration
- Core build up
- Liner
Device Description
Virto Fil LC is a dental cement that is composed of varoius materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges or to be applied to a tooth to protect the tooth pulp. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.
Ask a Question
Ask a specific question about this device
K Number
K123826Device Name
VITRO MOLAR
Manufacturer
Date Cleared
2013-02-14
(64 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DFL INDUSTRIA E COMERCIO S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Class I, Class II, Class III and Class V restorations .
- Non-bearing Class I and Class II restorations in permanent teeth .
- Intermediate restoration for heavy stress situations in Class I and Class II . cavities
- Core build up .
- Liner .
Device Description
Vitro Molar is a condensable, chemically activated glass ionomer cement, used in restorations of posterior teeth; it is radiopaque and offers good esthetic properties, easy manipulation, fast curing and it can be easily sculpted. It hardens via an acid/base reaction. Vitro Molar is also highly resistant to compression and bending, and has a hard, low-abrasive surface. It is ideal to be used in the atraumatic restorative treatment (ART) technique. Vitro Molar is for permanent cementation.
Ask a Question
Ask a specific question about this device
Page 1 of 1