Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides. The mechanical action of the solution moving in the root canal facilitates easy removal of debris and necrotic pulp tissue from the root canal.

AI/ML Overview

The Aquatine™ EC Endodontic Cleanser is deemed substantially equivalent based on non-clinical performance and biocompatibility data. The provided document, K061689, does not contain information about specific acceptance criteria or a study with detailed performance metrics, sample sizes, expert involvement, or comparative effectiveness studies that would be typical for an AI/ML powered device. Instead, the clearance is based on the device's similarity in function and intended use to existing legally marketed predicate devices and the fact that all components of Aquatine™ EC have been used in legally marketed devices.

Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The document is a 510(k) summary and clearance letter for a non-AI/ML medical device, which explains why these details are absent.

Summary

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K061689

AUG 2 4 2006

510(k) SUMMARY OF AQUATINE™ EC ENDODONTIC CLEANSER

510(k) Summary	This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of 21 C.F.R §807.92.
Submitter	PuriCore, Inc.320 King of Prussia RoadRadnor, PA 19087
Contact Person	Howard Mann320 King of Prussia RoadRadnor, PA 19087484-321-2703610-341-0503 fax
Date Prepared	August 8th, 2006
Trade Name	Aquatine™ EC
Common Name	Endodontic Cleanser
Classification Name	Cleanser, Root Canal
Predicate Devices	Pulpdent Sodium Hypochlorite Solution.; Pulpdent Corp., K962743,August 6th, 1996, Oxy-Glide Root Canal Cleanser & Lub.; Super GlideInc., K992919, Nov. 19th, 1999 and Biopure MTAD Root CanalCleanser Dentsply Intl., Inc., K053167, December 8th, 2005.
Description	Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides.The mechanical action of the solution moving in the root canal facilitateseasy removal of debris and necrotic pulp tissue from the root canal.
Indications for Use	Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse,and debride root canal systems.
Substantial Equivalence	The product is similar in function and intended use to:Pulpdent Sodium Hypochlorite Solution, manufactured by Pulpdent Corp. Oxy-Glide Root Canal Cleanser & Lub. manufactured by Super Glide Inc., that includes among its labeled uses the chemical and mechanical cleansing of root canal preparation during endodontic therapy. Biopure MTAD and Endopure Root Canal Cleansers manufactured by Dentsply Intl., Inc., that include among their labeled uses cleaning the canal and disinfecting the root canal system after endodontic instrumentation.
Non-clinical Performance	The performance and biocompatibility data provided support the safetyand effectiveness of Aquatine™ EC Endodontic Cleanser for theindicated uses. All components found in Aquatine™ EC EndodonticCleanser have been used in legally marketed devices
Conclusion	Aquatine™ EC Endodontic Cleanser is substantially equivalent to thecurrently cleared and marketed Pulpdent Sodium Hypochlorite Solution,Oxy-Glide Root Canal Cleanser & Lub, Endopure Root Canal Cleanserand Biopure MTAD Root Canal Cleanser.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is a stylized image of three human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2006

Mr. Howard K. Mann Vice President PuriCore, Incorporated 320 King of Prussia Road, Suite 200 Radnor, Pennsylvania 19087

Re: K061689

Trade/Device Name: Aquatine™ EC Endodontic Cleanser Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: KJJ Dated: August 10, 2006 Received: August 11, 2006

Dear Mr. Mann:

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 - Mr. Mann

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/cdrl/industry/support/index.html.

Sincerely vours.

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

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Indications for Use

Page 1 of

510(k) Number (if known): K061689

Device Name: Aquatine™ EC Endodontic Cleanser Indications for Use:

Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.

Susan Runner

(Sign-Off)

n of Anesthesiology, General Hospital, on Control, Dental Devices

Number: K061689

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The Counter Use (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)

Regulation Number and Section

N/A