BINGO PRO

K111474 · Forum Engineering Technologies (96) , Ltd. · LQY · Nov 2, 2011 · DE

Device Facts

• Record ID: K111474
• Device Name: BINGO PRO
• Applicant: Forum Engineering Technologies (96) , Ltd.
• Product Code: LQY · DE
• Decision Date: Nov 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

BINGO PRO is an electronic device used for precise apex localization and working length determination during root canal treatment. The device enables to obtain correct results in canals with different conditions - dry or wet.

Device Story

BINGO PRO is an electronic apex locator for root canal treatment. It uses AC signals at 500 Hz and 8 kHz to measure the root canal; the system calculates the RMS level of these signals to determine the file tip position. The device features a 3.5" color TFT display providing real-time visual feedback of endodontic file movement, including an 'APICAL ZOOM' feature for high-resolution monitoring in the apical zone. A 'VIRTUAL APEX' feature allows dentists to set a target position with visual and audio alerts. The device operates automatically without manual calibration and is compatible with stainless steel or nickel-titanium files. It is intended for use by qualified dental personnel in clinical settings to assist in determining working length, thereby helping the dentist achieve precise cleaning and shaping of the root canal.

Clinical Evidence

Ex-vivo bench testing performed on extracted teeth. The BINGO PRO was compared against the Dentaport ZX apex locator. Results demonstrated that apex localization accuracy is equivalent between the two devices and provides clinically acceptable results.

Technological Characteristics

Electronic apex locator; utilizes AC signals at 500 Hz and 8 kHz; RMS-based measurement method. Features 3.5" color TFT display, Micro-USB connector, and piezo transducer for audio feedback. Powered by 2.4V NiMH rechargeable batteries. Fully automatic operation; no manual calibration required. Compatible with stainless steel or nickel-titanium endodontic files.

Indications for Use

Indicated for precise apex localization and working length determination during root canal treatment in patients requiring endodontic procedures. Suitable for use in dry or wet root canal conditions. For use by qualified dental personnel in hospital, clinic, or dental office environments.

Predicate Devices

• Bingo-1020 (K992233)

Reference Devices

• Dentaport ZX apex locator

Submission Summary (Full Text)

{0}------------------------------------------------

| Forum Engineering Technologies (96) Ltd. | | |
|------------------------------------------|----------------|---------|
| BINGO PRO 510(k) File | 510(k) Summary | Rev. 04 |
| Document number: | 5-B31-003.FDA | |
| Effective Date: | Oct 23, 2011 | |
| | Page 1 of 6 | |

KII474

# "510(k) Summary"

NOV - 2 2011

## BINGO PRO, Electronic Apex Locator

The following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

Section's content

- રે ! . 807.92(a)(1)-Owner & Submitter's Details
- 807.92(a)(2) Candidate Device Details. 5.2.
- રે રે જેવી સાં 807.92(a)(3) - Predicate Device Identification
- 807.92(a)(4) Device Description ર્સ વર્ષ
- 807.92(a)(5) Intended Use 5.5.
- 807.92(a)(6) Substantial Equivalence Comparison Table ર્ડ.
- 807.92(b)(1) Brief discussion of the nonclinical tests 5.7.
- 807.92(b)(3) Conclusions ર જ

## 5.1. Owner & Submitter Details: [ 807.92(a)(1) }

Owner & Submitter Name:

Address:

- 1 Platin St., New Industrial Zone, Rishon Lezion 75653, Israel. Phone: [phone] Fax number: [phone] [e-mail] E-mail Name of Contact Person: Ms. Yuliya Yutkevich
Forum Engineering Technologies (96) Ltd.

#### US Agent:

NORMAN F.ESTRIN, PH.D., ESTRIN CONSULTING GROUP, INC. (ECG) 9109 Copenhaver Drive, Potomac, MD 20854 Phone: [phone] +001-301-294-0126 Fax: [e-mail] Email:

{1}------------------------------------------------

| Image: Forum Technologies Logo | Forum Engineering Technologies (96) Ltd. | |
|-----------------------------------|------------------------------------------|-------------|
| BINGO PRO 510(k) File | 510(k) Summary | Rev. 04 |
| Document number:<br>5-B31-003.FDA | Effective Date: Oct 23, 2011 | Page 2 of 6 |
| 5.2. Candidate Device Details: | [ 807.92(a)(2) ] | |
| Trade Name: | BINGO PRO – Electronic Apex Locator | |

| Trade Name: | BINGOS PRO - Electronic Apex Locator |
|----------------------|--------------------------------------|
| Common Name: | Apex Locator |
| Classification Name: | Locator, Root Apex |
| Product Code: | LQY -- Locator, ROOT APEX |
| Review Panel: | Dental |
| Device Class: | Unclassified |

#### 5.3. Predicate Device Identification: [ 807.92(a)(3) ]

Devices to which substantial equivalence is claimed:

| Table 5.3: Predicate Device Identification | | | | |
|---------------------------------------------|--|--|--|--|
|---------------------------------------------|--|--|--|--|

| Predicate<br>Device Name | Name of<br>Manufacturer | Name of Applicant | 510(k)<br>Number |
|--------------------------|----------------------------------------------------------|--------------------------------------------|------------------|
| Bingo-1020 | Forum Engineering<br>Technologies (96) Ltd.,<br>(Israel) | DENT CORP, Research<br>& Development (USA) | K992233 |

#### 5.4. Device Description: [ 807.92(a)(4) ]

BINGO PRO is a modern apex locator intended for precise localization of root canal apex.

The measurements in BINGO PRO 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 BINGO PRO is based on measurements of RMS (Root Mean Square) level of the signal.

Advanced 3D user interface implemented in BINGO PRO is based on high resolution TFT color graphic display. "Live" real time presentation of endodontic file movement inside the canal is designed to make dentist's work easier and to increase his confidence. Display indicators are carefully designed to be intuitively understood and to serve for instant troubleshooting during device usage.

BINGO PRO shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. ROOT WIZARD file tracking algorithm enables full-scale display of the file movement during the treatment while APICAL ZOOM feature enables high-resolution display of the file advance in preapical and apical zones. Large, clearly recognizable graphical and numerical readings in the 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

{2}------------------------------------------------

| Image: Forum Technologies Logo | Forum Engineering Technologies (96) Ltd. | | |
|-----------------------------------|------------------------------------------|-------------|--|
| BINGO PRO 510(k) File | 510(k) Summary | Rev. 04 | |
| Document number:<br>5-B31-003.FDA | Effective Date: Oct 23, 2011 | Page 3 of 6 | |

signals. Numerical values and the numerical scale 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 BINGO PRO 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. BINGO PRO may only be used with stainless steel or nickel titanium endodontic files.

According to the modern approach, the final distance of the probe tip from the apex should vary in different cases: for example, in non-contaminated root canal the tip should be about 0.5 mm before the minor apical foramen; in case of bacterial contamination the canal should be cleaned to the apex. Such cases may occur in different teeth of the same patient or even in the different canals of the same root. VIRTUAL APEX feature implemented in BINGO PRO enables to mark a predetermined indication position on the display in the APICAL ZOOM area. When VIRTUAL APEX feature is enabled, the dentist gets clear visual and audio feedback that the color bar indicating file tip position has reached the pre-selected point in the apical zone. If the virtual apex is set at the fifth bar, for example, the visual mark appears at 0.5 position. Additionally, special easily recognizable "VIRTUAL APEX" audio signal is activated when the color bar indicator reaches the virtual apex mark. Utilizing the VIRTUAL APEX feature, the dentist may choose to proceed either to the VIRTUAL APEX mark in non-contaminated canals or to the APEX indication in contaminated canals using visual or audio feedback. Numerical value of virtual apex mark does not represent actual distance from the apex in mm.

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

## 5.5. Intended Use: [807.92(a)(5)]

BINGO PRO is an electronic device used for precise apex localization and working length determination during root canal treatment. The device enables to obtain correct results in canals with different conditions - dry or wet.

## 5.6. Substantial Equivalence Comparison Table: [ 807.92(a)(6) ]

| Line<br>No. | Device<br>Characteristics | Predicate Device<br>Bingo-1020 | Candidate Device<br>BINGO PRO |
|-------------|---------------------------|-----------------------------------------------------------|-------------------------------|
| 1. | Device definition | Electronic apex locator | The same as in Bingo-1020. |
| 2. | Intended Use | Precise apex localization<br>during root canal treatment. | The same as in Bingo-1020. |

#### Table 5.6: Substantial Equivalence Comparison

{3}------------------------------------------------

| Image: Forum Technologies Logo | Forum Engineering Technologies (96) Ltd. | |
|--------------------------------|------------------------------------------|---------|
| BINGO PRO 510(k) File | 510(k) Summary | Rev. 04 |

Document number:

510(k) Summary

5-B31-003.FDA

Effective Date: Oct 23, 2011

| Line | Device | Predicate Device | Candidate Device |
|------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No. | Characteristics | Bingo-1020 | BINGO PRO |
| 3. | Indications for use | Bingo-1020 is a modern<br>device for precise apex<br>localization during root<br>channel treatment.<br>Bingo-1020 is distinguished<br>by increasing precision at<br>0.1mm on wet/dry, large<br>graphic display where<br>current position of endo file<br>is reflected and other<br>essential information is<br>displayed. | BINGO PRO is an electronic<br>device used for precise apex<br>localization and working<br>length determination during<br>root canal treatment. The<br>device enables to obtain<br>correct results in canals with<br>different conditions - dry or<br>wet. |
| 4. | Where to be used<br>(clinics, home etc.) | This product must only be<br>used in hospital<br>environments, clinics or<br>dental offices by qualified<br>dental personnel. | The same as in Bingo-1020. |
| 5. | Device category | Active, invasive | The same as in Bingo-1020. |
| 6. | Power Source | Low voltage NiMH<br>rechargeable batteries (3.6V) | Low voltage NiMH<br>rechargeable batteries (2.4V) |
| 7. | External charger | Input: 115V/50-60Hz<br>Output: 6V DC @ 200mA | Input: 120V/50-60Hz<br>Output: 6V DC @ 500mA. |
| 8. | Current<br>Consumption | Maximum -- 50 mA DC | Maximum - 250 mA DC. |
| 9. | Method of<br>calculating location<br>of root canal apex | RMS functions of the<br>measured signals at two<br>frequencies are used to<br>calculate the test scores,<br>which are compared to<br>statistically predefined<br>thresholds. | The same as in Bingo-1020. |
| 10. | Display | Custom monochrome LCD | 3.5" Color TFT Display |
| 11. | Buttons | Three pushbuttons:<br>1. On / Off<br>2. Sound control<br>3. MODE | The same as in Bingo-1020. |
| 12. | Sound indication | Piezzo transducer with<br>sound level control (high,<br>medium, low, mute) | The same as in Bingo-1020. |

{4}------------------------------------------------

| | | Forum Engineering Technologies (96) Ltd. | | | |
|------------------------------------------------------------|----------------------------------|------------------------------------------------|------------------------------------|------------------------|-------------------------------|
| BINGO PRO 510(k) File<br>Document number:<br>5-B31-003.FDA | | 510(k) Summary<br>Effective Date: Oct 23, 2011 | | Rev. 04<br>Page 5 of 6 | |
| Line<br>No. | Device<br>Characteristics | | Predicate Device<br>Bingo-1020 | | Candidate Device<br>BINGO PRO |
| 13. | Adjustment before<br>measurement | | Not required | | The same as in Bingo-1020 |
| 14. | Calibration | | Not required | | The same as in Bingo-1020 |
| 15. | Measuring signal<br>amplitude | | Nominal - doesn't exceed<br>25 VAC | | The same as in Bingo-1020 |

| 14. | Calibration | Not required | The same as in Bingo-1020. |
|-----|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 15. | Measuring signal amplitude | Nominal - doesn't exceed 25 mV AC. | The same as in Bingo-1020. |
| 16. | Frequencies used for measurements | 500 Hz and 8 kHz | The same as in Bingo-1020. |
| 17. | Weight | 430 Gr | 300 Gr |
| 18. | Dimensions | 160 x 95 x 35 mm | 74 x 120 x 70 mm |
| 19. | Endodontic Files to be used with the device | Bingo-1020 may only be used with stainless steel or nickel titanium endodontic files. | The same as in Bingo-1020. |
| 20. | Type of Connector | The type of connector used – Stereo plug. | The type of connector used – Micro-USB plug. |
| 21. | Automatic Turn-off function | The device turns off automatically after 5 min. of idle state. | The same as in Bingo-1020. |
| 22. | Display Zoom Area | Zoom area with the following graphical indications of file tip position:<br>1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, and 0.0.<br>Graphical indication of over-instrumentation. | Zoom area with the following graphical indications of file tip position:<br>2.0, 1.9, 1.8, 1.7, 1.6, 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, and 0.0.<br>Additionally file tip position is indicated in numerical form.<br>Over-instrumentation: graphical indication and additional alphanumerical presentation. |
| 23. | Virtual Apex feature | Basic Virtual Apex with audio feedback. | Advanced Virtual Apex with visual and audio feedback. |
| 24. | Training mode | Tutor Mode is implemented to demonstrate device operation and to shorten learning curve of the user. | DEMO mode is used for the same purposes. |

.

·

·

... ,

{5}------------------------------------------------

| | Forum Engineering Technologies (96) Ltd. | | | |
|-----------------------------------|------------------------------------------|------------------------------|-------------|--|
| BINGO PRO 510(k) File | | 510(k) Summary | Rev. 04 | |
| Document number:<br>5-B31-003.FDA | | Effective Date: Oct 23, 2011 | Page 6 of 6 | |

## 5.7. Brief discussion of the nonclinical tests [807.92(b)(1)]

To evaluate the performance of BINGO PRO apex locator, ex-vivo test was performed on extracted teeth. The results obtained with BINGO PRO were compared to the results of reference device - Dentaport ZX apex locator, which is used in many scientific studies and has FDA clearance. The conclusion of the test was that the apex localization obtained with both devices is essentially equivalent and that BINGO PRO provides clinically acceptable results.

## 5.8. Conclusions: [ 807.92(b)(3) ]

- BINGO PRO has the same intended use and fundamental scientific technology as . its predicate device - Bingo-1020 (K992233).
- BINGO PRO was evaluated against its predicate device, and was found to be ● Substantially Equivalent.

{6}------------------------------------------------

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

Ms. Yuliya Yutkevich Quality Assurance & Regulatory Affairs Manager Forum Engineering Technologies (96) Limited 1 Platin Street New Industrial Zone Rishon Lezion Israel 75653

NOV - 2 2011

Re: K111474

Trade/Device Name: BINGO PRO Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: October 25, 2011 Received: October 28, 2011

Dear Ms. Yutkevich:

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.

{7}------------------------------------------------

Page 2- Ms. Yutkevich

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony Watson, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

| Forum | Forum Engineering Technologies (96) Ltd. |
|--------------------------------|------------------------------------------|
| BINGO PRO 510(k) File | Indication for Use Statement |
| Document number: 5-B31-002.FDA | Effective Date: Aug 18, 2011 |
| | Rev. 02 |
| | Page 1 of 1 |

# Indication for Use Statement

## 510(k) Number (if known): K111474

Device Name:

## BINGO PRO

## Indications for Use:

BINGO PRO is an electronic device used for precise apex localization and working length determination during root canal treatment. The device enables to obtain correct results in canals with different conditions - dry or wet.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

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

510(k) Number: K111474