← Product Code LQY · K121206
# DETECT (K121206)
_Forum Engineering Technologies, Ltd. · LQY · Jan 10, 2013 · DE · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K121206
## Device Facts
- **Applicant:** Forum Engineering Technologies, Ltd.
- **Product Code:** LQY
- **Decision Date:** Jan 10, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** DE
## Intended Use
Detect is an electronic device used to indicate the location of the apex and the working length. This product must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
## Device Story
Detect is an electronic apex locator used by dental practitioners in clinical settings to determine root canal working length. The device inputs electrical signals via endodontic files (stainless steel or NiTi) inserted into the root canal. It utilizes two alternating AC frequencies (500 Hz and 8 kHz) to measure the RMS level of the signal, which is then compared against predefined thresholds to determine file tip position. The device provides real-time visual feedback on a TFT color display, including an 'Apical Zoom' feature for high-resolution monitoring of the apical zone, and optional audio signals. Operation is fully automatic, requiring no manual calibration. By providing continuous, accurate feedback on file position relative to the apex, the device assists the dentist in performing precise root canal procedures, potentially improving treatment outcomes and reducing the risk of over-instrumentation.
## Clinical Evidence
No clinical data. Performance was validated via ex-vivo bench testing on extracted teeth, comparing the Detect device to the predicate BINGO PRO. Results demonstrated that apex localization accuracy is equivalent between the two devices and clinically acceptable.
## Technological Characteristics
Active, invasive electronic apex locator. Uses two alternating AC frequencies (500 Hz and 8 kHz). RMS-based signal measurement. 3.5" TFT color display. Powered by 2.4V NiMH rechargeable batteries. Compatible with stainless steel or nickel titanium endodontic files. Automatic calibration and adjustment. IEEE 1394 connector. Dimensions: 80 x 130 x 63 mm; Weight: 360g.
## Predicate Devices
- BINGO PRO ([K111474](/device/K111474.md))
## Submission Summary (Full Text)
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| Forum Engineering Technologies (96) Ltd. | | |
|------------------------------------------|-----------------------------|-------------|
| Detect 510(k) File | Detect 510(k) Summary | Rev. 01 |
| Document number: 5-P22-003.FDA | Effective Date: Apr 8, 2012 | Page 1 of 5 |
K121206
# "510(k) Summary"
# Detect, Electronic Apex Locator
JAN 1 0 2013
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
- 807.92(a)(1) Owner & Submitter's Details 5.1.
- 807.92(a)(2) Candidate Device Details. 5.2.
- 807.92(a)(3) Cleared Device Identification 5.3.
- 5.4. 807.92(a)(4) Device Description
- 5.5. 807.92(a)(5) - Intended Use
- 5.6. 807.92(a)(6) - Substantial. Equivalence Comparison Table
- 807.92(b)(1) Brief discussion of the nonclinical tests 5.7.
- 807.92(b)(3) Conclusions રે જે
# 5.1. Owner & Submitter Details: { 807.92(a)(1) }
Owner & Submitter Name: Forum Engineering Technologies (96) Ltd. Address: 1 Platin St., New Industrial Zone, Rishon Lezion 75653, Israel. Phone: +972-3-9625517 Fax number: +972-3-9613355 E-mail info@forumtec.net Name of Contact Person: Ms. Yuliya Yutkevich
#### US Agent:
NORMAN F.ESTRIN, PH.D., ESTRIN CONSULTING GROUP, INC. (ECG) 9109 Copenhaver Drive, Potomac, MD 20854 Phone: +001-301-279-2899 Fax: +001-301-294-0126 Email: estrin@yourfdaconsultant.com
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### Section 5. Page 5-2
| Image: Forum Technologies logo | Forum Engineering Technologies (96) Ltd. | |
|-----------------------------------|------------------------------------------|-------------|
| Detect 510(k) File | Detect 510(k) Summary | Rev. 01 |
| Document number:
5-P22-003.FDA | Effective Date: Apr 8, 2012 | Page 2 of 5 |
| 5.2. Candidate Device Details: | [ 807.92(a)(2) ] | |
| Trade Name: | Detect - 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. Cleared Device Identification: [ 807.92(a)(3) |
Devices to which substantial equivalence is claimed:
#### Table 5.3: Predicate Device Identification
| Cleared Device
Name | Name of Manufacturer | 510(k)
Number |
|------------------------|------------------------------------------|------------------|
| BINGO PRO | Forum Engineering Technologies (96) Ltd. | K111474 |
#### 5.4. Device Description: [ 807.92(a)(4) ]
Detect is a modern apex locator intended for precise localization of root canal apex.
The measurements in Detect 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 Detect is based on measurements of RMS (Root Mean Square) level of the signal.
Advanced user interface implemented in Detect is based on high resolution TFT color graphic display. Clear 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.
Detect 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 and numerical 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. Numerical values and the numerical scale shown in the Apical Zoom do not represent actual distance from the
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| | Forum Engineering Technologies (96) Ltd. | |
|-----------------------------------|------------------------------------------|-----------------------|
| | Detect 510(k) File | Detect 510(k) Summary |
| Document number:
5-P22-003.FDA | Effective Date: Apr 8, 2012 | Page 3 of 5 |
apex in mm; they serve as a convenient reference to judge the file tip position in relation to the apex.
Operation of Detect 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. Very dry canals should be wetted by hypochlorite or saline solution. Full automation of the apex locator operation simplifies the use and increases the reliability of the measurements. Detect may only be used with stainless steel or nickel titanium endodontic files.
Built-in Demo mode of Detect 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)]
Detect is an electronic device used to indicate the location of the apex and the working length. This product must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
# 5.6. Substantial Equivalence Comparison Table: { 807.92(a)(6) }
#### Table 5.6: Substantial Equivalence Comparison
| Line | Device | Predicate Device | Candidate Device |
|------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No. | Characteristics | BINGO PRO | Detect |
| 1. | Device definition | Electronic apex locator | The same as in BINGO PRO. |
| 2. | Intended Use | Precise apex localization
during root canal treatment. | The same as in BINGO PRO. |
| 3. | 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. | Detect is an electronic device
used to indicate the location of
the apex and the working
length. This product must only
be used in hospital
environments, clinics or
dental offices, by qualified
practitioners. |
| 4. | Where to be used
(clinics, home etc.) | This product must only be
used in hospital
environments, clinics or
dental offices by qualified
dental personnel. | The same as in BINGO PRO. |
| 5. | Device category | Active, invasive | The same as in BINGO PRO. |
5-P22-003.FDA Detect 510(k) Summary of Safety and Effectiveness Rev. 01
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.
| Image: Forum Technologies logo | Forum Engineering Technologies (96) Ltd. | |
|-----------------------------------|------------------------------------------|-------------|
| Detect 510(k) File | Detect 510(k) Summary | Rev. 01 |
| Document number:
5-P22-003.FDA | Effective Date: Apr 8, 2012 | Page 4 of 5 |
.
| Line | Device | Predicate Device | Candidate Device | |
|------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--|
| No. | Characteristics | BINGO PRO | Detect | |
| 6. | Power Source | Low voltage NiMH
rechargeable batteries (2.4V) | The same as in BINGO PRO. | |
| 7. | External charger | Input: 120V/50-60Hz
Output: 6V DC @ 500mA. | The same as in BINGO PRO. | |
| 8. | Current
Consumption | Maximum - 250 mA DC. | The same as in BINGO PRO. | |
| 9. | Method of
calculating location
of root canal apex | RMS functions of the
measured signals at two
frequencies are used to
calculate the test scores,
which are compared to
statistically predefined
thresholds. | The same as in BINGO PRO. | |
| 10. | Display | 3.5" Color TFT Display | The same as in BINGO PRO. | |
| 11. | Buttons | Three pushbuttons:
1. On / Off
2. Sound control
3. MODE | Two pushbuttons:
1. On / Off
2. Sound control | |
| 12. | Sound indication | Piezzo transducer with
sound level control (high,
medium, low, mute). | The same as in BINGO PRO. | |
| 13. | Adjustment before
measurement | Not required | The same as in BINGO PRO. | |
| 14. | Calibration | Not required | The same as in BINGO PRO. | |
| 15. | Measuring signal
amplitude | Nominal - doesn't exceed
25 mV AC. | The same as in BINGO PRO. | |
| 16. | Frequencies used
for measurements | 500 Hz and 8 kHz | The same as in BINGO PRO. | |
| 17. | Weight | 300 Gr | 360 Gr | |
| 18. | Dimensions | 74 x 120 x 70 mm | 80 x 130 x 63 mm | |
| 19. | Endodontic Files to
be used with the
device | BINGO PRO may only be
used with stainless steel or
nickel titanium endodontic
files. | The same as in BINGO PRO. | |
| 20. | Type of Connector | The type of connector used -
Micro-USB plug. | The type of connector used -
IEEE 1394 plug. | |
| 21. | Automatic Turn-off
function | The device turns off
automatically after 5 min. of
idle state. | The same as in BINGO PRO. | |
5-P22-003.FDA Detect 510(k) Summary of Safety and Effectiveness Rev. 01
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| Detect 510(k) File | Detect 510(k) Summary | Rev. 01 | |
|-----------------------------------|-----------------------------|------------------|------------------|
| Document number:
5-P22-003.FDA | Effective Date: Apr 8, 2012 | Page 5 of 5 | |
| Line | Device | Predicate Device | Candidate Device |
| No. | Device Characteristics | Predicate Device
BINGO PRO | Candidate Device
Detect |
|-----|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 22. | Display Zoom Area | Zoom area with the
following graphical
indications of file tip
position:
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.
Additionally file tip position
is indicated in numerical
form.
Over-instrumentation:
graphical indication and
additional alphanumerical
presentation. | Zoom area with the following
graphical indications of file
tip position:
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.
Additionally file tip position
is indicated in numerical form.
Graphical indication of over-
instrumentation. |
| 23. | Virtual Apex
feature | Advanced Virtual Apex with
visual and audio feedback. | Virtual Apex feature is not
available. |
| 24. | Training mode | DEMO mode is
implemented to demonstrate
device operation and to
shorten learning curve of the
user. | The same as in BINGO PRO. |
#### 5.7. Brief discussion of the nonclinical tests [807.92(b)(1)]
To evaluate the performance of Detect apex locator, ex-vivo test was performed on extracted teeth. The results obtained with Detect were compared to the results of the FDA cleared device - BINGO PRO apex locator. The conclusion of the test was that the apex localization obtained with both devices is the same and that Detect provides clinically acceptable results.
# 5.8. Conclusions: [ 807.92(b)(3) ]
- Detect has the same intended use and fundamental scientific technology as the . cleared device - BINGO PRO (K111474).
- Detect was evaluated against the cleared device, and was found to be Substantially . Equivalent.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
#### January 10, 2013
Ms. Yuliya Yutkevich Quality Assurance & Regulatory Affairs Manager Forum Engineering Technologies (96) Limited 1 Platin Street, New Industrial Zone Rishon Lezion, Israel 7565339
Re: K121206
Trade/Device Name: Detect Regulation Number: Unclassified Regulation Name: Locator, Root Apex Regulatory Class: Unclassified Product Code: LOY Dated: December 20, 2012 Received: December 20, 2012
#### Dear Ms. Yukevich:
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. 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 devicerelated 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. 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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| Image: Forum Logo
Forum Engineering Technologies (96) Ltd. | | |
|---------------------------------------------------------------|---------------------------------------|-------------|
| Detect 510(k) File | Detect - Indication for Use Statement | Rev. 01 |
| Document number:
5-P22-002.FDA | Effective Date: March 13, 2012 | Page 1 of 1 |
#### Indication for Use Statement Section 4:
510(k) Number (if known): N/A
K/21206
Device Name:
Detect
#### Indications for Use:
Detect is an electronic device used to indicate the location of the apex and the working length. This product must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
1 Prescription Use (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)
2013.01.10 Susan Runner DDS, MA -11:40:34 -05'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Division of Anesthaslology, General Devices Division of Antaques. Dental Devices 2/206
**510(k) Number:**
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**Source:** [https://fda.innolitics.com/device/K121206](https://fda.innolitics.com/device/K121206)
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