AQUATINE EC ENDODONTIC CLEANSER

K061689 · Puricore, Inc. · KJJ · Aug 24, 2006 · DE

Device Facts

• Record ID: K061689
• Device Name: AQUATINE EC ENDODONTIC CLEANSER
• Applicant: Puricore, Inc.
• Product Code: KJJ · DE
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Aquatine™ EC Endodontic Cleanser is a liquid solution used by dental professionals during endodontic procedures. The device functions through mechanical action; the solution is introduced into the root canal system to irrigate, cleanse, and debride necrotic pulp tissue and debris. It is applied by clinicians in a dental office setting. The primary benefit is the facilitation of root canal preparation by removing biological material, thereby assisting in the cleaning of the canal system.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through non-clinical performance and biocompatibility testing.

Technological Characteristics

Liquid endodontic cleanser. Operates via chemical and mechanical irrigation/debridement. No electronic components, software, or energy sources.

Indications for Use

Indicated for irrigation, cleansing, and debridement of root canal systems during endodontic therapy.

Predicate Devices

• Pulpdent Sodium Hypochlorite Solution (K962743)
• Oxy-Glide Root Canal Cleanser & Lub (K992919)
• Biopure MTAD Root Canal Cleanser (K053167)

Reference Devices

• Endopure Root Canal Cleanser

Submission Summary (Full Text)

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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 being<br>submitted in accordance with the requirements of 21 C.F.R §807.92. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | PuriCore, Inc.<br>320 King of Prussia Road<br>Radnor, PA 19087 |
| Contact Person | Howard Mann<br>320 King of Prussia Road<br>Radnor, PA 19087<br>484-321-2703<br>610-341-0503 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,<br>August 6th, 1996, Oxy-Glide Root Canal Cleanser & Lub.; Super Glide<br>Inc., K992919, Nov. 19th, 1999 and Biopure MTAD Root Canal<br>Cleanser Dentsply Intl., Inc., K053167, December 8th, 2005. |
| Description | Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides.<br>The mechanical action of the solution moving in the root canal facilitates<br>easy removal of debris and necrotic pulp tissue from the root canal. |
| Indications for Use | Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse,<br>and debride root canal systems. |
| Substantial Equivalence | The product is similar in function and intended use to:<br>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 safety<br>and effectiveness of Aquatine™ EC Endodontic Cleanser for the<br>indicated uses. All components found in Aquatine™ EC Endodontic<br>Cleanser have been used in legally marketed devices |
| Conclusion | Aquatine™ EC Endodontic Cleanser is substantially equivalent to the<br>currently cleared and marketed Pulpdent Sodium Hypochlorite Solution,<br>Oxy-Glide Root Canal Cleanser & Lub, Endopure Root Canal Cleanser<br>and 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 [phone]. 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 [phone] or [phone] 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)

OR

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)