CITRIC ACID 20% SOLUTION, MODEL 329

K063703 · Ultradent Products, Inc. · KJJ · Dec 21, 2006 · DE

Device Facts

• Record ID: K063703
• Device Name: CITRIC ACID 20% SOLUTION, MODEL 329
• Applicant: Ultradent Products, Inc.
• Product Code: KJJ · DE
• Decision Date: Dec 21, 2006
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended Use

Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal.

Device Story

Citric Acid 20% Solution is a slightly thickened, orange-tinted, water-soluble root canal cleanser supplied in a 30 mL IndiSpense® syringe. Used by dentists during endodontic procedures, the solution is applied to canal walls to facilitate the removal of calcium hydroxide materials and to act as a mild etchant/conditioner for smear layer removal. By cleaning and exposing dentinal tubules, the device prepares the canal for obturation, potentially improving the quality of the root canal seal. The device is a chemical agent and does not involve electronic processing or automated decision-making.

Clinical Evidence

Bench testing only. A scanning electron microscope (SEM) study compared the efficacy of 10% citric acid, 20% citric acid, and EDTA in cleaning, chelating, and exposing dentinal tubules. Results indicated that 20% citric acid and EDTA were slightly more effective than 10% citric acid, though differences were not statistically significant. Safety is supported by literature review confirming non-cytotoxicity of citric acid.

Technological Characteristics

Chemical root canal cleanser consisting of 20% citric acid in a water-soluble, slightly thickened, orange-tinted solution. Supplied in a 30 mL IndiSpense® syringe. Functions as a chemical chelating agent and etchant. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a root canal cleanser to etch root canal walls prior to obturation in patients undergoing endodontic procedures.

Predicate Devices

• Citric Acid 10% Solution (K032627)

Submission Summary (Full Text)

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# 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.

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| Property | Citric Acid 20% Solution | Citric Acid 10%<br>Solution |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended Use | Facilitates removal of calcium<br>hydroxide from canal walls,<br>and functions as a mild<br>etchant/conditioner for smear<br>layer removal. | Same |
| Active Ingredient | Citric acid | Same |
| Biocompatibility/Safety | Clinical literature<br>demonstrates that citric acid<br>is safe and non-cytotoxic (see<br>Section VII) | Same |
| Properties | Orange-tinted, slightly<br>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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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

K063703

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(Posted November 13, 2003)