APX21

K073185 · Techdent Technologies, Ltd. · LQY · Mar 6, 2008 · DE

Device Facts

• Record ID: K073185
• Device Name: APX21
• Applicant: Techdent Technologies, Ltd.
• Product Code: LQY · DE
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point.

Device Story

APX21 is an electronic apex locator used by dental professionals to estimate endodontic file position within a root canal relative to the apex. Device employs bio-impedance principle; measures electrical impedance to track file depth. Output is displayed on a screen to provide visual feedback; audible signals assist the clinician during the procedure. Used in dental clinics; operated by trained general dentists. Provides real-time guidance during root canal treatments; helps clinicians accurately determine working length; potentially improves procedural precision and patient outcomes. Components contacting the patient are biocompatible and autoclavable.

Clinical Evidence

In-vitro and in-vivo studies compared APX21 to Morita's Root ZX. Both devices achieved high accuracy within the ±0.5 range. APX21 demonstrated superior stability and higher accuracy rates in-vivo, particularly when the accuracy criterion was narrowed to ±0.2. System components are biocompatible and autoclaveable. Electrical safety and EMC testing performed per IEC 60601.

Technological Characteristics

Electronic apex locator utilizing bio-impedance sensing principle. Components are biocompatible and autoclavable. Electrical safety and EMC tested per IEC 60601. Device provides visual screen output and audible signals.

Indications for Use

Indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry. Contraindicated for patients with implanted heart pacemakers or other equipment warned against use of small electrical appliances.

Predicate Devices

• Morita's Root ZX (K921979)

Submission Summary (Full Text)

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# K073185

MAR - 6 2008

# SECTION 5: 510(k) Summary

#### Submitter

Techdent Technologies Ltd. 55ª Weizman St. 22402 Nahariya ISRAEL Tel: [phone] Fax: [phone] E-mail: [e-mail]

## Contact Person

Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187, ISRAEL Tel: [phone] Fax: [phone] E-mail: benny(@arazygroup.com

#### Date Prepared

November, 2007

### Device Information

Trade name: APX21 Common name: Electronic Apex Locator Classification Name: locator, root apex Review Panel: Dental Product Code: LQY Device Class: Unclassified (Pre-Amendment)

## Devices to which substantial equivalence is claimed:

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## Device Description

The APX21 is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.

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## Indications for Use

The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.

## Performance

Prof. Pierre Machetou, who is renowned worldwide for his expertise in Endodontics, has tested the APX21 device in his clinic, and noted the following:

- Good ergonomics 트
- Precision comparable with the RZX on new treatments and re-treatments.
- Good audible signal I
- Should preferably be used on wet canal without exception of liquid
- I Excellent visibility on the screen

In-Vitro and In-Vivo studies were carried out to evaluate the performance of the new root-APX21. As part of the study, accuracy and stability of the APX21 were compared to those of Morita's Root ZX.

The APX21 proved to be unconditionally stable, while the RZX exhibited inherent instabilities at certain conditions.

The two devices achieved high rate of accuracy, falling well within the acceptable accuracy range criterion of ±0.5. Nevertheless, accuracy rates achieved with the APX21 In-Vivo were higher relative to the Root ZX, especially when unstable readings were taken into account and/or accuracy range criterion was narrowed down to ±0.2.

All system components that come in contact with the treated patient are biocompatible and autoclaveable.

System was Electrical safety and EMC tested per IEC 60601.

## Conclusion

Techdent's APX21, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when used as intended.

The APX21 has the same intended use and fundamental scientific technology as its predicate device - Morita's Root ZX (K921979).

The APX21 was extensively tested - both Bench and Clinically - against its predicate, and was found to be substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2008

Techdent Technologies Limited C/O Mr. Benny Arazy Chief Executive Officer and President Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL

Rc: K073185

Trade/Device Name: APX21 - Electronic Apex Locator Regulation Number: 21 CFR 872.3630 Regulation Name: Unclassified Regulatory Class: None Product Code: LQY Dated: January 30, 2008 Received: February 11, 2008

Dear Mr. Arazy:

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. Arazy

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 l'ederal 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 (OS) 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/cdrh/industry/support/index.html.

Sincerely yours,

fa. Snow Quong
Chiu Lin, Ph.D.

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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## SECTION 4: Indications for Use

510(k) Number:

Device Name: APX21 - Electronic Apex Locator

Intended Use:

The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point.

Indications for Use:

The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.

Contra Indications:

Do not use the APX21 on patients with implanted heart pacemakers or other equipment which have been warned against use of small electrical appliances.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

6073/85
8738