(436 days)
Not Found
Not Found
No
The 510(k) summary describes a dental cleanser used for rinsing surfaces and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a dental cleanser used for removing debris and smear-layer during dental procedures, which are preventative or restorative actions rather than therapeutic treatments for a disease.
No
This device is described as a "Dental Cleanser" used as an adjunctive rinse for procedures like caries restoration and chronic periodontitis treatment. Its stated purpose is to "assist in the removal of contaminated debris and smear-layer" or "help with the removal of contaminated debris from the sulcus." These are therapeutic or procedural functions, not diagnostic ones. A diagnostic device would be used to identify, detect, or monitor a medical condition or disease.
No
The 510(k) summary describes a dental cleanser, which is a physical substance, not software.
Based on the provided information, the EPIEN DENTAL CLEANSER is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses described are for cleaning and removing debris from exposed dentin and tooth root surfaces within the patient's mouth during dental procedures. This is a direct application to the patient's body, not the examination of specimens outside the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a topical application or rinse.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. The EPIEN DENTAL CLEANSER's function is purely mechanical/chemical cleaning within the oral cavity.
N/A
Intended Use / Indications for Use
EPIEN DENTAL CLEANSER is indicated for the following uses:
-
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.
-
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.
Product codes
KJJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin surfaces in cavity preparations, tooth root surfaces during periodontal debridement procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
September 9, 2021
EPIEN Medical, Inc. Reginald Dupre CEO 4225 White Bear Parkway Suite 600 St. Paul, Minnesota 55110
Re: K201785
Trade/Device Name: EPIEN Dental Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: August 24, 2021 Received: August 24, 2021
Dear Reginald Dupre:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201785
Device Name EPIEN Dental Cleanser
Indications for Use (Describe)
EPIEN DENTAL CLEANSER is indicated for the following uses:
-
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.
-
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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