(77 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the solution and its mechanical rinsing action, with no mention of AI or ML.
No
The device is a cleanser used to enhance the removal of debris during dental procedures, rather than directly treating a disease or condition.
No
Explanation: The device description and intended use clearly state that EPIEN ROOT CANAL CLEANSER is used as an "adjunctive rinse" to "enhance the removal of post-instrumentation dentinal debris and smear-layer." It is a cleansing agent for mechanical procedures, not a tool for diagnosing medical conditions.
No
The device is a chemical solution intended for irrigation, not a software program. The description details its chemical composition and physical properties, and the performance studies focus on its chemical and mechanical actions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems" during dental procedures. This is a mechanical or chemical action on the tooth structure, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a solution used to "irrigate root canals to provide a rinse to tooth surfaces." This further reinforces its function as a cleaning agent applied directly to the anatomical site.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, tissue, or fluid) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the "mechanical rinsing action," "desiccation effects," "biocompatibility," and "in vitro microbial biofilm disruption." These are all related to the physical and chemical properties and effects of the cleanser, not its ability to diagnose.
IVD devices are specifically designed to perform tests on samples from the human body to provide diagnostic information. This device's function is to clean a specific anatomical site during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth root canal systems and adjacent tooth surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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
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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:
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