PacEndo EDTA

K153528 · Pac-Dent International, Inc. · KJJ · Feb 1, 2016 · DE

Device Facts

• Record ID: K153528
• Device Name: PacEndo EDTA
• Applicant: Pac-Dent International, Inc.
• Product Code: KJJ · DE
• Decision Date: Feb 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Device Story

PacEndo™ EDTA is an aqueous EDTA solution containing a surfactant; used as an endodontic cleanser. Applied by clinicians during root canal procedures to remove smear layer and dentinal debris from canal walls post-instrumentation. Surfactant lowers surface tension to improve cleaning efficacy. Device is a liquid solution; used in dental clinics. Output is the physical removal of debris, facilitating subsequent obturation. Benefits include improved canal cleanliness for better sealing outcomes.

Clinical Evidence

No clinical data provided. Bench testing included surface tension measurement via contact angle analysis, which demonstrated similarity to the predicate device. Biocompatibility assessment and risk analysis were performed, concluding no additional biocompatibility testing was required.

Technological Characteristics

Aqueous solution containing EDTA, buffer, and surfactant. Clear liquid form. pH 7.56. Functions as a chemical root canal cleanser. No electronic or mechanical components.

Indications for Use

Indicated for use in endodontic procedures to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Predicate Devices

• EDTA Plus (K072555)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 1, 2016

Pac-dent International, Inc. Mr. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, California 92821

Re: K153528

Trade/Device Name: PacEndo™ EDTA Regulation Number: 21 CFR Regulatory Class: Unclassified Product Code: KJJ Dated: December 2, 2015 Received: December 9, 2015

Dear Mr. Zhu:

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.

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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pac-Dent International, Inc.

Section III

## Indications for Use Statement

510(k) Number (if known): _ K153528

Device Name: _ PacEndo™EDTA

Indications for Use:

PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

OR

Prescription Use _______________

C

Over-The-Counter Use

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Pac-Dent International, Inc.

# 510(k) Summary

510(k) Number: K153528

#### Submitter:

Pac-Dent International, Inc. 670 Endeavor Circle Brea, CA 92821

## Contact Person:

Wenying Zhu Materials Engineer 909-839-0888 ext.111

## Date Summary Prepared:

December 2015

Device Name Trade Name: PacEndo™ EDTA Common Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal Predicate Device EDTA Plus (K072555)

## Description of Device

PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.

## Indications for Use

PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Image /page/3/Picture/16 description: The image shows four different logos. The first logo is the FDA logo, which is gray and has the letters FDA in a stylized font. The second logo is the CE logo, which is blue and has the letters CE in a simple font. The third logo is the DTA logo, which is blue and has the letters DTA in a stylized font inside of a circle. The fourth logo is the OSAP logo, which is green and has the letters OSAP in a stylized font with the words "Because Safety Matters" below it and ".org" to the right.

IV-1

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| Comparison of Technological Characteristics | | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Descriptive<br>Information | Subject Device | Predicate Device | Summary |
| Indications for<br>Use | PacEndo™ EDTA | EDTA Plus (K072555) | |
| | PacEndo™ EDTA is intended to<br>facilitate removal of dentinal<br>debris from the walls of root<br>canals prior to obturation. | EDTA Plus is a root canal cleanser<br>designed to facilitate removal of<br>dentinal debris from the walls of<br>root canals prior to obturation. | The indications for<br>use of the subjective<br>and predicate<br>devices are the<br>same. |
| Composition of<br>Materials | EDTA<br>Buffer<br>Surfactant | EDTA<br>Buffer<br>Surfactant | The composition of<br>subject and predicate<br>devices is different.<br>However, the<br>functions of the<br>ingredients are the<br>same.<br>The difference<br>between the<br>composition of the<br>subject and predicate<br>devices doesn't affect<br>the substantial<br>equivalent of the<br>subject and predicate<br>devices. |
| Performance | Appearance: clear liquid<br>pH: 7.56 | Appearance: light peach color<br>liquid<br>pH: 7.55 | The appearances of<br>the subject and<br>predicate devices are<br>not the same.<br>However, it doesn't<br>affect the substantial<br>equivalent of the<br>subject and predicate<br>devices. |

## Comparison of Technological Characteristics

Based on the above comparisons, Pac-Dent concludes that the subject device is substantially

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1

IV-2

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equivalent in intended use, composition and performance to the predicate device.

#### Non-Clinical Tests

Surface tension test using contact angle measurement was performed in comparison to the predicate device.

A biocompatibility assessment and risk analysis were conducted and the results demonstrated that no biocompatibility testing was needed to demonstrate biocompatibility of the device for the intended use.

#### Clinical Performance Test

No clinical testing was provided.

#### Summary of Non-Clinical and Clinical Performance Testing_

The subject device was found to have similar surface tension compared to the predicate device and can be used as intended.

#### Conclusion

In summary, non-clinical performance testing demonstrates that PacEndo™ EDTA is substantially equivalent to the identified predicate product for its intended use.

Image /page/5/Picture/12 description: The image shows a series of logos for different organizations. From left to right, the logos are for FDA, CE, DIA, and OSAP. The OSAP logo includes the tagline "Because Safety Matters" and the website address ".org".