ASEPTICO ENDOPEX V, MODEL AEU-40

K030895 · Aseptico, Inc. · LQY · Dec 3, 2003 · DE

Device Facts

• Record ID: K030895
• Device Name: ASEPTICO ENDOPEX V, MODEL AEU-40
• Applicant: Aseptico, Inc.
• Product Code: LQY · DE
• Decision Date: Dec 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.

Device Story

Endopex V (AEU-40) is an electronic apex locator used by dentists in clinical settings. Device utilizes two electrodes: one attached to an endodontic file inserted into the tooth, and one contacting the oral cavity (lip). System measures electrical impedance between these electrodes. Internal software compares measured impedance against a stored database of values. Results are converted into visual LED indicators representing the estimated position of the file relative to the root canal and apical foramen. By providing real-time feedback on file depth, the device assists the clinician in navigating the root canal, potentially reducing the number of diagnostic radiographs required during endodontic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic apex locator; utilizes two-electrode impedance measurement system. Output provided via LED display. Device is a standalone unit.

Indications for Use

Indicated for use by dentists to estimate the position of an endodontic file within a root canal during endodontic surgery to reduce the need for radiographs.

Submission Summary (Full Text)

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K030895

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Aseptico Inc. 8333 216th Street SE Woodinville, Washington 98072 Phone: [phone] Fax: [phone]

## 510(k) Summary

Contact: Grant Ramaley

Date Prepared: March 17, 2003

Trade of Proprietary Name: Aseptico Endopex V Model Number AEU-40

Classification Name: Unclassified

Product Code: LQY - Locator, Root Apex

## Endopex V operating principals

Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip.

The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2003

Mr. Grant Ramaley Quality and Regulatory Affairs Manager Aseptico Incorporated 8333 216th Street SE Woodinville, Washington 98072

Re: K030895

Trade/Device Name: Endopex V Model AEU-40 Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LQY Dated: February 3, 2003 Received: September 4, 2003

Dear Mr. Ramaley:

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 marketcd 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 Fedcral 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. Ramaley

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 vour 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runor

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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510(k) Number (if known): K030895

Device Name: ENDOPEX V Model AEU-40

Indications For Use:

The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.

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Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801 109)

OR

Over-The-Countern Use

(Optional Format 1-2-96)

Robert S. Betz, DDS for Dr. Susan Runner

Division of Anesthesiology, General Hospital, Infection Contro

510(k) Number: K030875