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510(k) Data Aggregation
K Number
K201785Device Name
EPIEN Dental Cleanser
Manufacturer
EPIEN Medical, Inc.
Date Cleared
2021-09-09
(436 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EPIEN Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EPIEN DENTAL CLEANSER is indicated for the following uses:
1) Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer.
2) Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.
Device Description
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K Number
K123538Device Name
EPIEN ROOT CANAL CLEANSER
Manufacturer
EPIEN MEDICAL, INC.
Date Cleared
2013-02-01
(77 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EPIEN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems.
Device Description
EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous and dense solution that is used to irrigate root canals to provide a rinse to tooth surfaces as an adjunctive to professional mechanical dental procedures. The EPIEN ROOT CANAL CLEANSER is applied onto tooth root canal surfaces for a brief duration using standard dental irrigation syringes. It is then rinsed away with saline or water. EPIEN ROOT CANAL CLEANSER cleanses the root canal system by enhancing the removal of the post-instrumentation smear layer.
The EPIEN ROOT CANAL CLEANSER consists of hydroxybenzenesulfonic acid, hydroxymethoxybenzenesulfonic acid, sulfuric acid, and water, in addition to a colorant.
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