EPIEN MEDICAL, INC.

FDA Device Registration & Listing · White Bear Lake, MN, US · Registration 3003428492

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003428492
FEI Number
3003428492
Entity Name
EPIEN MEDICAL, INC.
City/State/Country
White Bear Lake, MN, US
Establishment Address
4225 White Bear Parkway, SUITE 600, White Bear Lake, MN 55110, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EPIEN MEDICAL, INC. (Owner Number: 9088699)
Owner / Operator Contact Address
4225 White Bear Parkway, SUITE 600, White Bear Lake, MN 55110, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201785
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KJJ Cleanser, Root Canal Unknown Class U N/A 2021-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EPIEN MEDICAL, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2020 Inter-Med Llc U
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020 Inter-Med Llc U
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003428492. Last updated year: 2026. Please use registration number 3003428492 when referencing this establishment in official correspondence.
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