Epien Medical, Inc.

Address:4225 White Bear Parkway,White Bear Lake,MN,55110,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cleanser, Root Canal (KJJ) (1)

Premarket Exempt

Clear

HYBENX Root Canal Cleanser - 00860004740308 Catalog Number :

Device Description : EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth r 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 system.

Device Class : U

Duns Number: 128678765

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

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