← Product Code KJJ · K123538 # EPIEN ROOT CANAL CLEANSER (K123538) _Epien Medical, Inc. · KJJ · Feb 1, 2013 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K123538 ## Device Facts - **Applicant:** Epien Medical, Inc. - **Product Code:** KJJ - **Decision Date:** Feb 1, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE ## 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 Story EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous solution containing hydroxybenzenesulfonic acid, hydroxymethoxybenzenesulfonic acid, sulfuric acid, and a colorant. Used by dental professionals in a clinical setting as an adjunctive rinse during root canal procedures. Applied to tooth root canal surfaces via standard dental irrigation syringes; rinsed away with saline or water. Mechanism involves mechanical rinsing action and superficial dehydration of material in instrumented root canals, reducing attachment of dentinal debris and smear layer to tooth surfaces. Facilitates removal of smear layer post-instrumentation, improving thoroughness of mechanical cleaning. Benefits include enhanced cleanliness of root canal systems. ## Clinical Evidence No human clinical trials. Evidence includes 36-month real-time stability studies, ISO 10993-1 biocompatibility testing (cytotoxicity, sensitization, mutagenicity, irritation, intracutaneous reactivity), and chemical/physical characterization (viscosity, acidity, erosion assays). In vitro microbial biofilm disruption assays (MBEC, root rinse tests) and animal performance testing (canine oral mucosa metabolism, IV ADME, vital pulp and periodontal tissue exposure) were conducted to support safety and efficacy. ## Technological Characteristics Aqueous solution of hydroxybenzenesulfonic acid, hydroxymethoxybenzenesulfonic acid, and sulfuric acid. Moderately viscous. Applied via standard dental irrigation syringes. Biocompatibility tested per ISO 10993-1. Characterized by acid titration, viscosity, and hygroscopicity. Non-electronic, non-implantable, chemical-based cleanser. ## Predicate Devices - Ultradent Citric Acid 20% Solution ([K063703](/device/K063703.md)) - DENTSPLY International Biopure™ MTAD™ Root Canal Cleanser ([K053167](/device/K053167.md)) - PuriCore, Inc Aquatine™ EC Endodontic Cleanser ([K061689](/device/K061689.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) Summary for EPIEN ROOT CANAL CLEANSER FEB 0 1 2013 | Submitter/Holder | EPIEN Medical, Inc.
4225 White Bear Parkway
Suite 600
St. Paul, MN 55110-3389 | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Reginald Dupre
CEO
EPIEN Medical, Inc.
4225 White Bear Parkway
Suite 600
St. Paul, MN 55110
Ph: 651.653.3380 ext.102
Fax: 651.653.8569
Email:rdupre@epien.com | | Date Prepared | November 13, 2012 | | Trade Name | EPIEN ROOT CANAL CLEANSER | | Common Name | Tooth Root Canal Cleanser | | Classification
Name | Root Canal Cleanser, Unclassified | | Predicate Devices | K063703, Ultradent Products Ultradent Citric Acid 20% Solution K053167, DENTSPLY International Biopure™ MTAD™ Root Canal Cleanser K061689, PuriCore, Inc Aquatine™ EC Endodontic Cleanser | | 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. | | 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. | | Characteristics | EPIEN ROOT CANAL CLEANSER improves the thoroughness of mechanical cleaning procedures by
providing a mechanical rinsing action to the surfaces of the tooth root. EPIEN ROOT CANAL
CLEANSER also provides superficial dehydration of material in instrumented tooth root canal systems
on contact. This causes reduction of the attachment of dentinal debris and the smear layer to tooth
surfaces. This disruption assists with the removal of the smear layer. | | Performance Data | The performance data provided support the safety and effectiveness of the EPIEN ROOT CANAL | | | mechanical rinsing action of the product and desiccation effects. The studies demonstrate that the
product is safe and effective for its intended use. Biocompatibility studies indicate that the product is
non-toxic, non-sensitizing, a non-irritant, and non-mutagenic.
The following studies were conducted:
• 36-month real-time stability/shelf-life studies
• Biocompatibility studies in accordance with ISO 10993-1 (cytotoxicity, sensitization, mutagenicity,
irritation, and intracutaneous reactivity)
• Chemical and physical characterization studies (Chromatographic Analyses, Acid Titration
Curve/Total Acidity, Viscosity, Hygroscopicity, Exothermia on Solvation, Enamel and Dentin
Erosion Assays)
• In vitro microbial biofilm disruption assays (Disclosing Solution Demonstration, MBEC Assays,
Dental root canal and root surface rinse test)
• Animal Performance Testing (Canine Oral Mucosa Metabolism and IV ADME of c14-ERCC,
Canine Vital Pulp ERCC Exposure Study, and Canine Periodontal tissue ERCC Exposure Study) | | Predicates
Comparison | The proposed device is substantially equivalent to the currently cleared and marketed devices. The
EPIEN ROOT CANAL CLEANSER is equivalent in intended use, design characteristics, and method of application to predicate devices.
The composition of the EPIEN ROOT CANAL CLEANSER represents a different technology from the predicates in that it is composed of an aqueous solution of sulfonated aromatics and free sulfuric acid.
The questions of safety and effectiveness that have applied to the predicates also apply to the EPIEN ROOT CANAL CLEANSER in an identical manner. The results from biocompatibility, bench, and animal studies demonstrate that any differences between the EPIEN ROOT CANAL CLEANSER and the predicate devices do not constitute a new intended use, affect safety or effectiveness, or raise different questions of safety and effectiveness.
The information submitted in this 510(k) support a determination of Substantial Equivalence for the EPIEN ROOT CANAL CLEANSER product. | {1}------------------------------------------------ . {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 ### February 1, 2013 Epien Medical, Incorporated C/O Mr. Jeffery K. Shapiro Director Hyman Phelps & McNamara. P.C. 700 Thirteenth Street, North West, Suite 200 WASHINGTON DC 20005 Re: K123538 Trade/Device Name: Epien Root Canal Cleanser Regulation Number: Unclassified Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: November 16, 2012 Received: November 16, 2012 #### Dear Mr. Shapiro: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Anthong ls m Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ EPIEN MEDICAL. INC. EPIEN ROOT CANAL CLEANSER Original Premarket 510(k) Notification Volume 001 File 006 ## Indications for Use **510(k) Number (if known):** K123538 Device Name: EPIEN ROOT CANAL CLEANSER Indications for 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. Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Andrew I. Steen 2013.02.01 10:09:42 -05'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: Page 1 of 1 .............................................................................................................................................................................. Page 006-2 .. . . . . . . . . .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • --- **Source:** [https://fda.innolitics.com/device/K123538](https://fda.innolitics.com/device/K123538) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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