Search Results
Found 22 results
510(k) Data Aggregation
K Number
K152826Device Name
NoCord
Manufacturer
CENTRIX, INC.
Date Cleared
2016-05-27
(241 days)
Product Code
ELW, MVL
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord
1. Retracts the gingival tissue to expose the sub-gingival margin
2. Controls gingival bleeding
3. Reproduces the structure of a patient's teeth and gums
Device Description
NoCord is a low viscosity vinyl polysiloxane impression material.
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K Number
K140144Device Name
BENDA WEDGE
Manufacturer
CENTRIX, INC.
Date Cleared
2014-07-08
(167 days)
Product Code
EJB
Regulation Number
872.4565Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.
Device Description
Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.
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K Number
K120176Device Name
SENZZZZZ AWAY
Manufacturer
CENTRIX, INC.
Date Cleared
2012-07-25
(187 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To relieve dental hypersensitivity.
Device Description
Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.
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K Number
K111348Device Name
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
Manufacturer
CENTRIX, INC.
Date Cleared
2011-07-22
(70 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.
Device Description
Re/Stasis™ is a paste containing kaolin clay and aluminum chloride
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K Number
K092384Device Name
LIQUICORD
Manufacturer
CENTRIX, INC.
Date Cleared
2009-11-04
(91 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiquiCord is intended for temporary retraction and hemostatsis of the gingival margin during dental procedures such as dental impressions and the seating of temporary and permanent restorations
Device Description
Not Found
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K Number
K091380Device Name
CORDCAP
Manufacturer
CENTRIX, INC.
Date Cleared
2009-07-30
(80 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.
Device Description
CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
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K Number
K021131Device Name
CHLORAPREP
Manufacturer
CENTRIX, INC.
Date Cleared
2002-09-26
(171 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CLEANING AND Disinfective RESTORA ીચ્ચનો work
Device Description
Not Found
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K Number
K021146Device Name
D/SENSE 1-STEP
Manufacturer
CENTRIX, INC.
Date Cleared
2002-07-02
(84 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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K Number
K010133Device Name
VERSALUX
Manufacturer
CENTRIX, INC.
Date Cleared
2001-04-05
(78 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001050Device Name
CALCIJECT
Manufacturer
CENTRIX, INC.
Date Cleared
2000-07-21
(112 days)
Product Code
EJK
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
CENTRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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