ENDOPURE ROOT CANAL CLEANSER

K032361 · Dentsply Intl. · KJJ · Jan 12, 2004 · DE

Device Facts

• Record ID: K032361
• Device Name: ENDOPURE ROOT CANAL CLEANSER
• Applicant: Dentsply Intl.
• Product Code: KJJ · DE
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

EndoPure™ Root Canal Cleanser is used to chemically clean and disinfect a root canal system after endodontic instrumentation.

Device Story

EndoPure™ Root Canal Cleanser is a two-part liquid/powder formulation used for chemical cleaning and disinfection of root canals post-instrumentation. It removes the smear layer and kills bacteria without damaging tooth structure or soft tissue. The device is dispensed via a disposable syringe by dental professionals in a clinical setting. It serves as an adjunct to mechanical instrumentation to improve root canal hygiene.

Clinical Evidence

No clinical data provided. Biocompatibility testing (cytotoxicity and mutagenicity) was performed, finding the device to be non-cytotoxic and non-mutagenic.

Technological Characteristics

Two-part liquid/powder formulation. Dispensed via disposable syringe. Biocompatible components previously used in legally marketed devices.

Indications for Use

Indicated for chemical cleaning and disinfection of root canal systems following endodontic instrumentation. Contraindicated in patients with hypersensitivity to doxycycline or other tetracyclines.

Predicate Devices

• EDTA Root Canal Cleanser (K003422)

Submission Summary (Full Text)

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#### 510(k) SUMMARY K632361

### NAME & ADDRESS: DENTSPLY International

JAN 1 2 2004

70 West College Avenue k. PA 17405-0872 71845-751

P. J. Lehn Telefax [phone]

| CONTACT: | P. Jeffery Lehn |
|----------------------------|------------------------------------|
| DATE PREPARED: | JUL 30 2003 |
| TRADE OR PROPRIETARY NAME: | EndoPure™ Root Canal Cleanser |
| CLASSIFICATION NAME: | Root Canal Cleanser (unclassified) |
| PREDICATE DEVICES: | EDTA Root Canal Cleanser K003422 |

DEVICE DESCRIPTION: EndoPurc™ Root Canal Cleanser is a two-part liquid/powder formulation. The mixed solution cleanses the root canal, removes the smear layer, and kills the bactcria in an instrumented root canal without harming the tooth structure or soft tissue.

The EndoPure™ Root Canal Cleanser is easily dispensed using a disposable syringe.

INTENDED USE: EndoPure™ Root Canal Cleanser is used to chemically clean and disinfect a root canal system after endodontic instrumentation.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in F.ndoPure™ Root Canal Cleanser been used in legally marketed devices.

EndoPure™ Root Canal Cleanser has been cvaluated for cytotoxicity and mutagenicity and found to be non-cytotoxic and non-mutagenic.

We believe that the prior use of the components of EndoPurc™ Root Canal Cleanser in Iegally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of FindoPure™ Root Canal Cleanser for the indicated uses.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The overall design is simple and conveys a sense of national identity and governmental authority.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 2 2004

Mr. P. Jeffery Lehn Mr. P. Jeffery Echn
Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K032361

K032501
Trade/Device Name: EndoPure™ Root Canal Cleanser Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 23, 2003 Received: December 24, 2003

Dear Mr. Lehn:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 lo(K) prematics by cquivalent (for the indications for the indications for referenced above and have determined the devices marketed in interstate commerce
use stated in the enclosure) to legally market of the Madical American or to devices that use stated in the enclosure) to icgally that clevice Amender ...
prior to May 28, 1976, the enactment date of the Medical Econ ... . . . . . . . . . . . . . . . . . . . . . . prior to May 28, 1976, the enactment cate of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal From PMA ). You may have been reclassified in accordance will the provisions of wall application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of th Act (Act) that do not require apployal othe general controls provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of t therefore, market the device, subject to the generation, listing of devices, good
controls provisions of the Act include requirements for annial registration, controls provisions of the Act metude requirements for and adulteration.
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 If your device is classified (see above) into class in (openar ons affecting your device can be
may be subject to such additional controls. Existing mayor regulations FDA m may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition found in the Code of I cueral reegariations,
further announcements concerning your device in the Federal Register.

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Page 2 - Mr. P. Jeffery Lehn

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its to!l-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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): _K032361

EndoPure™ Root Canal Cleanser Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Used to chemically clean and disinfect a root canal system after endodontic instrumentation

### Contraindication:

EndoPure™ is contraindicated for persons who have shown hypersensitivity to doxycycline or any other tetracyclines.

Prescription Use
(21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saser Rumm
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number_KG

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