Search Results
Found 3 results
510(k) Data Aggregation
K Number
K150423Device Name
EXPAZEN
Manufacturer
PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP)
Date Cleared
2015-07-08
(139 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EXPAZEN is a paste containing aluminum chloride which is intended to be used for temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Device Description
EXPAZEN is a paste containing aluminum chloride.
Ask a Question
K Number
K111978Device Name
SULCUS BLUE
Manufacturer
PRODUITS DENTAIRES PIERRE ROLLAND
Date Cleared
2011-10-13
(93 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRODUITS DENTAIRES PIERRE ROLLAND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
Device Description
SULCUSBLUE is a paste containing aluminium chloride which is used, in association with compression caps (SULCUSCAP), for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
The paste is applied directly into the sulcus thanks to the a cannula. It is left in place between 1 and 2 minutes depending upon the tonicity of the marginal and removed by an air and water spray with simultaneous aspiration. A dry retracted sulcus is obtained.
Ask a Question
K Number
K050180Device Name
EXPA-SYL
Manufacturer
PRODUITS DENTAIRES PIERRE ROLLAND
Date Cleared
2005-02-11
(16 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PRODUITS DENTAIRES PIERRE ROLLAND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Expa-syl is a paste containing aluminum chloride which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Device Description
Expa-syl is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. The paste is extruded through the tip attached to the cartridge and applied into the sulcus through the use of the manual dispensing gun. The paste is left in place between 1 to 2 minutes, depending upon the tonicity of the marginal gingiva, and then removed by an air and water spray with simultaneous aspiration. A dry, retracted sulcus is obtained.
Ask a Question
Page 1 of 1