(94 days)
024198, 950365
SmearClear®, K# 024198, Moyco-EDTA, K# 950365
No
The description focuses on the chemical composition and intended use of a root canal cleanser, with no mention of AI or ML technologies.
No
The device is a cleanser used to prepare the root canal for filling, not to treat a disease or condition itself.
No
Explanation: The device is described as a "root canal cleanser" used to clean and remove debris from root canals, which is a therapeutic function, not a diagnostic one. It facilitates a procedure but does not provide information for diagnosis.
No
The device description clearly states it is a "peach-colored aqueous solution" in a bottle, indicating it is a chemical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate removal of dentinal debris from the walls of root canals prior to obturation." This is a procedure performed on the patient's tooth, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description confirms its use "during/After endodontic instrumentation" to "clean the canal space and remove the smear layer." This is a direct application within the patient's mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease, or providing information about a patient's health status based on laboratory testing.
Therefore, EDTA Plus is a medical device used in a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EDTA Plus is a root canal cleanser designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Product codes
KJJ
Device Description
EDTA Plus is a root canal cleanser for use in endodontic procedures. During/After endodontic instrumentation, the product should be used to clean the canal space and remove the smear layer before placement of the endodontic filling. The material can be delivered into the canal using a side-vented, closed tip irrigation needle.
The device consists of a 16 oz. bottie of EDTA Plus, a peach-colored aqueous solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
SmearClear®, K# 024198, Moyco-EDTA, K# 950365
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Exhibit #1
510(k) SUMMARY
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: - 1072551
-
- Submitter's Identification: Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
Date Summary Prepared: September 6, 2007
- Submitter's Identification: Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
Contact: Mr. Brian Rasimick
2. Name of the Device:
EDTA Plus
3. Predicate Device Information:
-
SmearClear®, K# 024198, Sybrori Dental Specialties, Inc., Orange, CA
-
Moyco-EDTA, K# 950365, Union Broach, Div. Moyco Industries, Inc. Emigsville, PA
4. Device Description:
EDTA Plus is a root canal cleanser for use in endodontic procedures. During/After endodontic instrumentation, the product should be used to clean the canal space and remove the smear layer before placement of the endodontic filling. The material can be delivered into the canal using a side-vented, closed tip irrigation needle.
The device consists of a 16 oz. bottie of EDTA Plus, a peach-colored aqueous solution.
5. Intended Use:
EDTA Plus is a root canal cleanser designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of four human profiles facing to the right, stacked on top of each other.
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Rasimick Research & Development Manager Essential Dental Systems, Incorporated 89 Leuning Street, Suite 8 South Hackensack, New Jersey 07606
Re: K072555
Trade/Device Name: EDTA Plus Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: KJJ Dated: November 28, 2007 Received: November 30, 2007
Dear Mr. Rasimick:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 -Mr. Rasimick
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Junne
Chin-Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Exhibit B
Indications for Use
Page __ of _1
510(k) Number (if known): 5072655
Device Name: EDTA Plus
Indications for Use:
EDTA Plus is a root canal cleanser designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over the Counter Use (Per 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Brunner
ology, General Hos
vi, Dental Devic