RAYPEX 6

K131907 · Dentsply International, Inc. · LQY · Jan 31, 2014 · DE

Device Facts

• Record ID: K131907
• Device Name: RAYPEX 6
• Applicant: Dentsply International, Inc.
• Product Code: LQY · DE
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

RAYPEX® 6 is a microprocessor controlled device used for locating the apex.

Device Story

RAYPEX® 6 is a microprocessor-controlled electronic apex locator used by dental professionals in clinical settings. It inputs AC signals at 500 Hz and 8 kHz into the root canal to measure the RMS level of the signal, determining the position of the endodontic file tip relative to the apex. The device features a 3.5-inch color TFT touch display providing real-time graphical feedback of file movement, supplemented by optional audio signals. An 'Apical Zoom' feature provides high-resolution visualization of the file in pre-apical and apical zones. Operation is fully automatic, requiring no manual calibration, and functions in both dry and wet canal conditions. A 'Check mode' allows for automated verification of device and accessory integrity. The device aids clinicians in determining working length during root canal procedures, potentially improving treatment precision.

Clinical Evidence

Bench testing only. An ex-vivo study was conducted using extracted teeth to compare the performance of RAYPEX® 6 against the predicate BINGO PRO apex locator. The study evaluated measurement accuracy in various conditions, including the presence of different irrigation liquids. Results demonstrated that RAYPEX® 6 measurements are clinically acceptable and equivalent to the predicate device.

Technological Characteristics

Electronic apex locator; utilizes AC signals at 500 Hz and 8 kHz; measures RMS signal levels. Features 3.5-inch color TFT touch display. Powered by 2.4V NiMH rechargeable batteries. Includes automatic turn-off, audio feedback via speaker, and built-in 'Check mode' for system verification. Microprocessor-controlled. Form factor: 350g handheld unit.

Indications for Use

Indicated for use by qualified dental personnel in hospital, clinic, or dental office settings for the localization of the root canal apex during endodontic treatment.

Predicate Devices

• BINGO PRO apex locator (K111474)

Submission Summary (Full Text)

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# 1131907

JAN 3 1 2014

Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word appears to be a logo or brand name.

SECTION 5. 510(k) SUMMARY for RAYPEX® 6

- 5.1 Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405 USA

Contact Person: Helen Lewis Telephone Number: 717-487-1332 Fax Number: 717-849-4343

Date Prepared: January 27, 2014

- 5.2 Candidate Device Details:
- Trade name/Proprietary Name: RAYPEX® 6 .
- Common Name: .
- Classification Name: .
- Product Code: .
- Review Panel: .
- Device Class: .

Apex Locator Locator, Root Apex LOY - Locator, ROOT APEX Dental Unclassified (Pre-Amendment)

### 5.3 Predicate Device Identification:

Device to which substantial equivalence is claimed is BINGO PRO apex locator of Forum Engineering Technologies (96) Ltd. (Israel), 510(k) number K111474.

### 5.4 Device Description:

RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex.

The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal.

Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal.

# DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 [phone] Fax [phone] www.dentsply.com

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RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex.

Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet.

Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device.

Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories.

For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.

- 5.5 Indications for Use:
RAYPEX® 6 is a microprocessor controlled device used for locating the apex.

| Device Characteristic | Predicate Device<br>BINGO PRO | Proposed Device<br>RAYPEX® 6 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K111474 | Pending |
| Device Definition | Electronic apex locator | Electronic apex locator |
| Device Category | Active, invasive | Active, invasive |
| Indications for Use | BINGO PRO is an<br>electronic device used for<br>precise apex location and<br>working length<br>determination during root<br>canal treatment. The device<br>enables to obtains correct<br>results in canals with<br>different conditions-dry or<br>wet. | RAYPEX® 6 is a<br>microprocessor controlled<br>device used for locating the<br>apex. |
| Weight | 300g | 350g |
| Where to be used | This product must only be<br>used in hospital<br>environments, clinics or<br>dental offices by qualified<br>dental personnel. | This product must only be<br>used in hospital<br>environments, clinics or<br>dental offices by qualified<br>dental personnel. |

- 5.6 Substantial Equivalence Comparison

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| Device Characteristic | Predicate Device<br>BINGO PRO<br>(K111474) | Proposed Device<br>RAYPEX® 6 |
|--------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display | 3.5" color TFT<br>(portrait orientation) | 3.5" color TFT<br>(landscape orientation) |
| Training mode | DEMO mode is used to<br>demonstrate device<br>operation and to shorten<br>learning curve of the user. | DEMO mode is used to<br>demonstrate device<br>operation and to shorten<br>learning curve of the user. |
| Check mode | Not available. | "Check mode" built-in<br>feature utilizing dedicated<br>tester allows checking<br>operation of both the device<br>and the accessories. |
| Power Source | NiMH rechargeable<br>batteries (2.4V) | NiMH rechargeable<br>batteries (2.4V) |
| Extrenal charge | Input: 120V/50-60Hz<br>Output: 6V DV @ 500mA | Input: AC 100-240V:<br>50/60Hz<br>Output: 5VDC @ 1,000mA |
| Automatic Turn-Off<br>function | The device turns off<br>automatically after 5 min.<br>of idle state. | The device turns off<br>automatically after 5 min.<br>of idle state. |
| Sound indication | Piezzo transducer with<br>sound level control (high,<br>medium, low, mute) | Speaker which enables:<br>-sound level adjustment<br>from mute to high sound<br>level<br>-tone selection |
| Additional features | Not available | For practioner's<br>convenience user interface<br>setup is available, including<br>selection of:<br>• Display background<br>color<br>• Sound type<br>• Display brightness |

#### 5.7 Non-Clinical/Clinical Performance Data

To evaluate the performance of RAYPEX® 6 apex locator, ex-vivo test was performed on extracted teeth. The results obtained with RAYPEX® 6 were compared to the results of the FDA cleared device - BINGO PRO apex locator.

The conclusions of the test were that the measurements of RAYPEX® 6 apex locator are clinically acceptable since they are equivalent to the results of BINGO PRO device and that RAYPEX® 6 measurements in presence of different, irrigation liquids are clinically acceptable.

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- 5.8 Conclusion as to Substantial Equivalence
- RAYPEX® 6 has the same intended use and fundamental scientific . technology as its predicate device - BINGO PRO (K111474).
- The similarities in the design, indications for use, fundamental product . technology, and the results of comparative performance testing support the substantial equivalence of the RA YPEX® 6 to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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" around the perimeter. Inside the circle is a stylized symbol resembling a human figure embracing a bird, which is a common emblem associated with the department.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### January 31, 2014

DENTSPLY International Ms. Helen Lewis Director, Corporate Regulatory Affairs Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Re: K131907

Trade/Device Name: RAYPEX® 6 Regulation Number: Unclassified Regulation Name: Locator, Root Apex Regulatory Class: Unclassified Product Code: LQY Dated: December 20, 2013 Received: December 24, 2013

Dear Ms. Lewis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Lewis

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/5/Picture/7 description: The image shows the name Kwame Ulmer in bold black font. Below the name is the acronym FDA in a stylized font. The letters are large and blocky, and they appear to be made up of smaller squares or rectangles.

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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 STATEMENT

510(k) Nümber (if known):: K 131907

Device Name; RAYPEX® 6

Indications for Uses

RAYPEX® 6 is a microprocessor controlled device used for lacating the apex.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BECOW THIS LINE-GONFINUE ON ANQTHER PAGE IF NERDED)

Concurrence of CDRH. Office of Device Busination (ODE)

Mary S. Runner -5 Saces Room Dog not 2014.01.28 13:53:26 -05:00.

> 000008 DENISTA International