← Product Code KJJ · K160577 # PacEndo Chlorhexidine (K160577) _Pac-Dent International, Inc. · KJJ · Jul 25, 2016 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K160577 ## Device Facts - **Applicant:** Pac-Dent International, Inc. - **Product Code:** KJJ - **Decision Date:** Jul 25, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** DE - **Attributes:** Therapeutic ## Intended Use PacEndo Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation. ## Device Story PacEndo Chlorhexidine is a 2% chlorhexidine gluconate solution containing surfactants to reduce surface tension. It is used by dental professionals in a clinical setting to irrigate and cleanse root canal systems after mechanical instrumentation. The solution acts as a chemical cleanser to facilitate the removal of debris and microorganisms from the canal. The clinician applies the solution directly into the root canal system. The device benefits the patient by assisting in the disinfection and preparation of the root canal prior to obturation. ## Clinical Evidence Bench testing only. Comparative performance testing evaluated pH and surface contact angle against the predicate device. Results demonstrated that the subject device performs equivalently to the predicate in these metrics. ## Technological Characteristics 2% Chlorhexidine Gluconate solution with surfactant. Liquid form. Non-sterile (implied by intended use as a cleanser). No electronic components, software, or energy sources. ## Predicate Devices - CHX and CHX-Plus™ ([K112250](/device/K112250.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 25, 2016 Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 670 Endeavor Circle Brea, California 92821 Re: K160577 Trade/Device Name: PacEndo™ Chlorhexidine Regulation Number: n/a Regulation Name: n/a Regulatory Class: Unclassified Product Code: KJJ Dated: June 8, 2016 Received: June 15, 2016 #### Dear Ms. 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. {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803); 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160577 Device Name PacEndo Chlorhexidine Indications for Use (Describe) PacEndo Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Section IV # 510(k) Summary ## 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: Feb 19 2016 ## Device Name Trade Name: PacEndo™ Chlorhexidine Common Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal Predicate Device CHX and CHX-Plus™ (K112250) ## Description of Device PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures. ## Indications for Use PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation. ## Comparison of Technological Characteristics {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Pac-Dent International, Inc. The logo features the word "PacDent" in a bold, blue font, with an orange swoosh above it. To the right of "PacDent" is the text "Pac-Dent International, Inc." in a smaller, gray font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products. | Descriptive
Information | Subject Device
PacEndo™ Chlorhexidine | Predicate Device
CHX and CHX-Plus™ (K112250) | Summary | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for
Use | PacEndo™ Chlorhexidine is
intended to irrigate and cleanse
root canal systems after
endodontic instrumentation. | CHX and CHX-Plus™ are used as
a final endodontic rinse after
instrumentation to irrigate and
cleanse the root canal system for
long lasting cleansing | Although the wording is not
identical, both devices are used
for endodontic procedures to
irrigate and cleanse the root
canal. | | Composition of
Materials | Chlorhexidine Gluconate
Surfactant | Chlorhexidine Gluconate
Surfactant
Colorant | The functions of the ingredients in
subject and predicate devices are
the same. | | Performance | Appearance: clear to light
yellow liquid
pH Testing
Surface Contact Angle Testing | Appearance: clear to light blue
liquid
pH Testing
Surface Contact Angle Testing | The difference between the
appearances of the subject and
predicate devices doesn't affect
the substantial equivalent of the
subject and predicate devices. | Based on the above comparisons, Pac-Dent concludes that the subject device is substantially equivalent in intended use, composition and performance to the predicate device. ## Non-Clinical Tests Comparative testing was done to the noted predicate device for both pH and surface contact angle. The results of the comparative testing demonstrate that the subject device performs as well as the noted predicate in the surface contact angle testing and that both devices share similar pH values. ## Conclusion In summary, non-clinical performance testing demonstrates that PacEndo™ Chlorhexidine is substantially equivalent to the identified predicate product for its intended use. --- **Source:** [https://fda.innolitics.com/device/K160577](https://fda.innolitics.com/device/K160577) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com