(8 days)
Not Found
No
The device description and performance studies focus on the chemical properties and efficacy of citric acid as a root canal cleanser, with no mention of AI or ML technology.
No
Explanation: A therapeutic device is designed to treat or alleviate a disease, injury, or medical condition. While this device cleans and etches root canal walls, which is part of a dental procedure, its primary function is preparatory for a seal, not directly treating a disease or condition in a therapeutic sense. It's a procedural aid for dental cavity preparation.
No.
The device is a root canal cleanser and etchant, intended for therapeutic use to prepare root canal walls, not to diagnose a condition.
No
The device description clearly states it is a "slightly thickened, water-soluble solution" provided in a syringe, indicating it is a chemical substance and a physical delivery mechanism, 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 "etch root canal walls just prior to obturation to allow an optimum seal" and to "facilitate removal of calcium hydroxide materials... from canal walls" and "as a mild etchant/conditioner for smear layer removal." These are all actions performed on the patient's tooth structure (in vivo), not on a sample taken from the patient (in vitro) for diagnostic purposes.
- Device Description: The description details a solution used for cleaning and etching within the root canal, which is a direct treatment application.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a condition, measure a substance in a sample, or provide information about a patient's health status based on testing a biological sample.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely therapeutic and preparatory for a dental procedure.
N/A
Intended Use / Indications for Use
Facilitates removal of calcium hydroxide from canal walls, and functions as a mild etchant/conditioner for smear layer removal. (from "Product Comparsion Table")
Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal. (from "INDICATIONS FOR USE")
Product codes
KJJ
Device Description
Citric Acid 20% is a slightly thickened, water-soluble solution. It is slightly orange-tinted for easy identification and is provided in a 30 ml IndiSpense® Syringe. Citric Acid facilitates removal of calcium hydroxide materials (e.g., UltraCal®) from canal walls. It can also be used as a mild etchant/conditioner for smear layer removal. Ultradent's EDTA 18%, a chelating agent, is an alternative for this purpose. Regardless of regimen used, we recommend a final rinse with clean, bacteria-free water, plain EDTA or local anesthetic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal walls
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
A scanning electron microscope study was performed to evaluate the ability of EDTA, 10% citric acid and 20% citric acid in cleaning, chelating and exposing dentinal tubules. The results showed that more dwelling time allowed the irrigants to function more effectively in cleaning and exposing dentinal tubules. It appeared that 20% citric acid and EDTA were slightly more effective than 10% citric acid; however, these differences did not appear to be significant.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the number '06', then '37', and ends with '03'. The handwriting appears to be somewhat rough, but the characters are still legible.
SPECIAL 510(k) PREMARKET SUMMARY
Ultradent Citric Acid 20% Solution
UEL 2 1 2006
This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Citric Acid 20% Solution.
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | Corey Jaseph |
|---|---|
| Title: | Regulatory Affairs Product Specialist |
| Telephone: | 800-552-5512 x4586, 801-553-4586 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | December 11, 2006 |
Name of the Device
| Trade Name: | Citric Acid 20% Solution |
|---|---|
| Common Name: | Cleanser, Root Canal |
| Risk Classification: | Unclassified (pre-amendment) |
| Classification Product Code: | KJJ |
Legally Marketed Predicate Devices to Which Equivalence is Claimed:
Predicate: Citric Acid 10% Solution, Ultradent Products, Inc. (K032627). Manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, UT 84095.
Product Description and Intended Use:
Citric Acid 20% is a slightly thickened, water-soluble solution. It is slightly orangetinted for easy identification and is provided in a 30 ml IndiSpense® Syringe. Citric Acid facilitates removal of calcium hydroxide materials (e.g., UltraCal®) from canal walls. It can also be used as a mild etchant/conditioner for smear layer removal. Ultradent's EDTA 18%, a chelating agent, is an alternative for this purpose. Regardless of regimen used, we recommend a final rinse with clean, bacteria-free water, plain EDTA or local anesthetic.
1
| Property | Citric Acid 20% Solution | Citric Acid 10%
Solution |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended Use | Facilitates removal of calcium
hydroxide from canal walls,
and functions as a mild
etchant/conditioner for smear
layer removal. | Same |
| Active Ingredient | Citric acid | Same |
| Biocompatibility/Safety | Clinical literature
demonstrates that citric acid
is safe and non-cytotoxic (see
Section VII) | Same |
| Properties | Orange-tinted, slightly
thickened | Same |
| How Supplied | 30 mL IndiSpense® Syringe | Same |
Table 1: Product Comparison Table
Technological Characteristics
Citric acid has been used as an irrigant during root canal procedures for many years. One of its attractive features is its non-cytotoxicity, while still being effective in removing calcium hydroxide and the smear layer caused by instrumentation. Many different concentrations of citric acid have been used, with varying degrees of success. Both 10 and 20% solutions are used successfully for these purposes (see Section VII, Literature Review).
Brief Description of Testing Performed and Conclusion
A scanning electron microscope study was performed to evaluate the ability of EDTA, 10% citric acid and 20% citric acid in cleaning, chelating and exposing dentinal tubules. The results showed that more dwelling time allowed the irrigants to function more effectively in cleaning and exposing dentinal tubules. It appeared that 20% citric acid and EDTA were slightly more effective than 10% citric acid; however, these differences did not appear to be significant.
Substantial Equivalence
In conclusion, Citric Acid 20% Solution, to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, UT 84095, is substantially equivalent to Citric Acid 10% Solution, also manufactured by Ultradent Products, Inc. The two products are composed of the same materials, have the same intended use and both are safe and effective for use for the indications described.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Corey Jaseph Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
DEC 2 1 2006
Re: K063703
Trade/Device Name: Ultradent Citric Acid 20% Solution Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 11, 2006 Received: December 13, 2006
Dear Ms. Jaseph:
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.
3
Page 2 - Ms. Corey Jaseph
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 (OS) 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal.
Prescription Use X (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)
Suser Gunner
University General Hospital
Central Sterile Services
Page_1_of_1
(Posted November 13, 2003)