← Product Code LQY · K101054
# ROMIAPEX MODEL A-15 (K101054)
_Romidan, Ltd. · LQY · Sep 3, 2010 · DE · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K101054
## Device Facts
- **Applicant:** Romidan, Ltd.
- **Product Code:** LQY
- **Decision Date:** Sep 3, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** DE
## Intended Use
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
## Device Story
RomiApex™ A-15 is an electronic apex locator used by dental professionals in clinics to measure the distance to the root apex during root canal procedures. The device applies a low-frequency, low-voltage AC signal (500 Hz and 8 kHz) between a lip electrode and an endodontic file inserted into the canal. As the file advances, the device measures the changing impedance of the tissues between the electrodes. The system alternates between the two frequencies rather than mixing them, eliminating the need for signal filtering and reducing noise. The device consists of a main body with a color LCD display, a lip clip, a file clip, a cable, and a probe. It is powered by a 1.5V AAA alkaline battery. The healthcare provider monitors the file's progress on the LCD display, which assists in precise apex localization, potentially improving the accuracy and safety of the root canal treatment.
## Clinical Evidence
No clinical data provided; substantial equivalence is based on bench testing and technological comparison to the predicate device.
## Technological Characteristics
Electronic apex locator; powered by 1.5V AAA alkaline battery. Uses AC signals at 500 Hz and 8 kHz. Features a color LCD display, lip clip, file clip, and micro-USB connector. Operates via impedance measurement between electrodes. No external charger required. Automatic shut-off after 5 minutes of idle state.
## Predicate Devices
- BINGO-1020 ([K992233](/device/K992233.md))
## Submission Summary (Full Text)
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K101054
RomidanLtd.
premium quality products
5. Simcha Holzberg St., 55022 Kiryat Ono, Israel.
图 +972-3-7360099 export@romidan.com 록 +972-3-7360097 Web: www.romidan.com
Document No .: 05.00
#### "510(k) Summary" Section 5.:
C
SEP 3 · 2010
## RomiApex™ A-15, 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
- 807.92(a)(1) Owner & Submitter's Details 5.1.
- 807.92(a)(2) Candidate Device Details. 5.2.
- 5.3. 807.92(a)(3) - Predicate Device Identification:
- 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)(3) Conclusions 5.7.
### 5.1 Owner &Submitter's Details: [ 807.92(a)(1) ]
| Owner & Submitter Name: | Romidan LTD |
|-------------------------|-------------------------------------------------|
| Address: | 5 Simcha Holzberg St., 55022 Kiryat Ono, Israel |
| Phone: | +972-3-7360099 |
| Fax number: | +972-3-7360097 |
| E-mail | eitan@romidan.com |
| Name of Contact Person: | Mr. Eitan Margalit |
Establishment Registration No.: 3003518307
Date prepared:
July 18t, 2010
### US Agent:
15.00 100701-6 51000 Summenr of Sulaty and Effe
NORMAN F.ESTRIN, PH.D., ESTRIN CONSULTING GROUP, INC. (ECG) 9109 Copenhaver Drive, Potomac, MD 20854 Phone: +001-301-279-2899 +001-301-294-0126 Fax: estrin@yourfdaconsultant.com Email:
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Image /page/1/Picture/0 description: The image shows the logo for Romidan Ltd. The logo features a diamond shape on the left, followed by the company name in bold, sans-serif font. Below the company name, the words "premium quality products" are written in a smaller, italicized font.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel. 粵 +972-3-7360097 @ +972-3-7360099 export@romidan.com Web: www.romidan.com
Document No .: 05.00
| 5.2 Candidate Device Details: | [ 807.92(a)(2) ] |
|-------------------------------|-----------------------------------------|
| Trade Name: | RomiApex™ A15 – 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 Medical
Device Name | Applicant Name | 510(k)
Number(*) |
|----------------------------------|-----------------------------------|---------------------|
| BINGO-1020 | DENT CORP, Research & Development | K992233 |
(4) See "510(k) Premarket Notification Database Search for more details.
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table. (see Para 807.92(a)(6)).
### 5.4 Device Description: [ 807.92(a)(4) ]
- The RomiApex™ A-15 is used to measure the distance to the apex during root � canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.
- The RomiApex™ A-15 operates on the measurement of a weak electrical current . flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal.
- The measurements in RomiAPEX™ A-15 are performed utilizing AC signals at . two frequencies - 500 Hz and 8 kHz. The frequencies are alternated rather then mixed, as it is done in other apex locators, thus canceling the need for signal filtering and eliminating the noise caused by non-ideal filters.
- The device consists of a main body incorporating the LCD display, a lip Clip, a file . clip a cable and a touch prob.
- The device is powered by one 1.5 AAA Alkaline battery. .
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows a logo for Romidan LTD. The logo features a diamond shape on the left, followed by the word "Romidan" in bold, sans-serif font. To the right of "Romidan" is "LTD." in a smaller font size. Below "Romidan" is the phrase "premium quality products" in a smaller, italicized font, underlined with a solid line.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel. 图 +972-3-7360099 톰 +972-3-7360097
export@romidan.com (a)
Web: www.romidan.com
Document No .: 05.00
## 5.5 Intended Use : [ 807.92(a)(5) ]
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
### 5.6 Substantial Equivalence Comparison Table: [ 807.92(a)(6) ]
| Line
No. | Device
Characteristics | Predicate Device
Bingo-1020 | Candidate Device
RomiApex™ A-15 |
|-------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Device definition | Electronic apex locator | Same as in Bingo-1020 |
| 2. | Intended Use | Precise apex localization during
root canal treatment. | Same as in Bingo-1020 |
| 3. | Indications for use | Bingo-1020 is a modern device
for precise apex localization
during root channel treatment.
Bingo-1020 is distinguished by
increasing precision at 0.1mm
on wet/dry, large graphic
display where current position
of endo file is reflected and
other essential information is
displayed. | RomiAPEX™ A-15 is indicated
for patients who need to
undergo root canal treatment,
which requires precise
determination of position of the
dental file in the canal relatively
to the root apex. |
| 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. | Same as in Bingo-1020 |
| 5. | Device category | Active, invasive | Same as in Bingo-1020 |
| 6. | Power Source | 2.4V NiMH rechargeable
batteries | 1.5V alkaline primary battery |
| 7. | External charger | Input: 230V/50-60Hz
Output: 6Vdc @ 200mA | External charger is not required |
| 8. | Current Consumption | Maximum - 30 mA DC. | Maximum – 13 mA DC. |
| 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. | Same as in Bingo-1020 |
| 10. | Display | Custom monochrome LCD
Display | Custom color LCD Display |
| Line | Device | Predicate Device | Candidate Device |
| No. | Characteristics | Bingo-1020 | RomiApex™ A-15 |
| 11. | Buttons | Three push buttons:
1. On / Off
2. Sound control
3. Demo MODE
(training mode) | Two push buttons:
1. Same as in Bingo-1020
2. Same as in Bingo-1020
3. "Demo MODE" (for training)
is not an offered feature in
RomiApex™ A-15. |
| 12. | Sound indication | Piezo transducer with sound
level control (high, medium,
low, mute). | Same as in Bingo-1020 |
| 13. | Adjustment before
measurement | Not required | Same as in Bingo-1020 |
| 14. | Calibration | Not required | Same as in Bingo-1020 |
| 15a. | Measuring signal | Nominal - doesn't exceed 25
mV AC. | Same as in Bingo-1020 |
| 15.b | amplitude | The maximum voltage applied
to the patient doesn't exceed
300 mV DC. | Same as in Bingo-1020 |
| 16. | Frequencies used for
measurements | 500 Hz and 8 kHz | Same as in Bingo-1020 |
| 17. | Weight | 430 Gr | 100 Gr |
| 18. | Dimensions | W160 x H95 x T35 mm | W55 x H92 x T16mm |
| 19. | Files to be used with
the device | Any kind of standard
dental
files may be used | Same as in Bingo-1020 |
| 20a. | Safety features | The same connector on the
device is used both for
measuring cable connection
and for battery charging.
This safety feature prevents
simultaneous connection of the
device to the patient and to the
mains via external charger. | No external charger should be
connected to the device. And
due that such safety feature is
not needed in RomiApex™ A-
15 at all. |
| 20b. | Safety features
(Continue) | The type of connector used -
Mini DIN | A new type of connector is
used - Micro USB.
This type of connector was
specially designed to provide
particularly high mechanical
strength and is guaranteed by
the manufacturer for 10,000
mating cycles. |
| 21. | Automatic on/off
switch | Automatic turn-off after 5 min.
of the idle state. | Same as in Bingo-1020 |
### Table 5.6: Substantial Equivalence Comparison
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Image /page/3/Picture/0 description: The image shows a logo for Romidan Ltd. The logo features a diamond shape on the left, followed by the word "Romidan" in bold, and "Ltd." in smaller font. Below the company name, the words "premium quality products" are printed in a smaller font with a line underneath.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel.
图 +972-3-7360099 | | |
惠 +972-3-7360097
Document No.: 05.00
@ export@romidan.com
Web: www.romidan.com
End of Table 5.6
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Image /page/4/Picture/0 description: The image shows the logo for Romidan Ltd. The logo features a diamond shape on the left, followed by the company name in bold, black letters. Below the company name, the words "premium quality products" are written in a smaller font.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel.
图 +972-3-7360099
g
export@romidan.com
鳥 +972-3-7360097 Web: www.romidan.com
Document No .: 05.00
### 5.7 Conclusions: [ 807.92(b)(3) ]
- Romidan's RomiApex™ A-15, 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 use as intended.
- The RomiApex™ A-15 has the same intended use and fundamental scientific . technology as its predicate device - Bingo 1020 (K992233)
- The RomiApex™ A-15 was evaluated against it's predicate, and was found to be . Substantial Equivalent.
{5}------------------------------------------------
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Eitan Margalit General Manager Romidan, Limited 5 Simcha Holzberg Street Kirvat Ono Israel 55022
2010 SEP 3
Re: K101054
Trade/Device Name: RomiApex™ A-15, (an Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LOY Dated: August 26, 2010 Received: August 30, 2010
Dear Mr. Margalit:
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- Mr. Margalit
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Antony D. Anatan
Anthony D. Watson, B.S., M.S., M.B.A. 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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K101054
| Romidan Ltd. | | |
|---------------------------------------------------|------------------------------|--------------------------|
| 5, Simcha Holzberg St., 55022 Kiryat Ono, Israel. | | |
| +972-3-7360099 | +972-3-7360097 | |
| eitan@romidan.com | Web: www.romidan.com | |
| Device Name: | RomiApex™ A-15 | Valid from: 4/9/2010 |
| Document No.: | 04.00 | Section 4; Page 1 (of 1) |
| Document Name: | Indication for Use Statement | |
2010 SEP 3
#### Indication for Use Statement Section 4 .:
510(k) Number (if known):
RomiApex™ A-15, (an Apex Locator) Device Name:
Indications for Use:
- RomiAPEX™ A-15 is indicated for patients who need to undergo root canal . treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
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)
&oncurrence of CDRH, Office of Device Evaluation (ODE)
Susan Renner
Division Sign-OH) livision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K110154
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4-1 (Page 1 of 1)
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