Diammine Silver Fluoride Dental Hypersensitivity Varnish

Device Code: 1379

Product Code(s): PHR

Definition: Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.

Device Classification Information

Device Type ID1379
Device NameDiammine Silver Fluoride Dental Hypersensitivity Varnish
Physical StateLiquid, Gel
Technical MethodPrecipitates Upon Application Resulting In A Physical Blockage Of Dentinal Tubules
Target AreaTooth Enamel
Regulation DescriptionCavity Varnish.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.3260 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePHR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1379
DeviceDiammine Silver Fluoride Dental Hypersensitivity Varnish
Product CodePHR
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCavity Varnish.
CFR Regulation Number872.3260 [🔎]
Premarket Reviews
ManufacturerDecision
COOLEY CONSULTING, INC.
 
SUBSTANTIALLY EQUIVALENT
1
SDI LIMITED
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 19:53:05

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