MULTIPLE (APEX LOCATOR), MODEL RCM-7

K090925 · J. Morita USA, Inc. · LQY · Nov 23, 2009 · DE

Device Facts

• Record ID: K090925
• Device Name: MULTIPLE (APEX LOCATOR), MODEL RCM-7
• Applicant: J. Morita USA, Inc.
• Product Code: LQY · DE
• Decision Date: Nov 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

Device Story

RCM-7 is a dental apex locator used to detect the root canal apex. Device operates by measuring electrical impedance within the root canal to determine the position of the file tip relative to the apex. Used in dental clinics by dentists or dental professionals. Output is provided to the clinician to assist in determining the working length during endodontic procedures, facilitating accurate root canal treatment and potentially improving patient outcomes by preventing over-instrumentation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and performance specifications to predicate devices.

Technological Characteristics

Dental apex locator; impedance-based measurement principle. Design and materials are similar to predicate devices. Electrical safety and thermal safety profiles are consistent with established dental device standards.

Indications for Use

Indicated for use as an apex locator to detect the apex of a root canal in dental patients.

Predicate Devices

• Root ZX (K921979 / K953867)
• DP-ZX-VL (K071190)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

## J. MORITA USA Inc.'s RCM-7

K090925

96

#### 1. NAME OF DEVICE

(

1. NAME OF DEVICE

| Common/Usual Name: | Apex Locator | NOV 2 3 2009 |
|-----------------------------------|-------------------------|--------------|
| Device trade or proprietary name: | Multiple (Apex Locator) | |

*The device may be sold under multiple product names including Root ZX mini.

| Product Model Name : | RCM-7 |
|----------------------|-------|
|----------------------|-------|

2. SUBMITTER NAME AND ADDRESS WITH PHONE/FAX

Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA 949-581-9600 Telephone: Facsimile: 949-581-9688

Registration No. 3002807636 Manufacturer: J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 [phone] [phone]

## 3. CONTACT PERSON

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]

#### March 19, 2009 4. DATE SUMMARY PREPARED:

# 5. DEVICE CLASSIFICATION/CLASSIFICATION PANEL

| Device: | Locator, Root Apex |
|---------------|--------------------|
| Review Panel: | 872 Dental |
| Product Code: | LQY |
| Device Class: | Unclassified |

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## 6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE

#### DEVICE DESCRIPTION

The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

#### SUBSTANTIAL EQUIVALENCE

## The RCM-7 is substantially equivalent to Root ZX (K921979 / K953867) and the Canal Measurement Module of DP-ZX-VL (K071190).

#### 1) Predicate device I : Root ZX (K921979 / K953867)

The RCM-7 is substantially equivalent to Root ZX from J.MORITA MFG.CORP. The RCM-7 has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device Root ZX (K921979 / K953867).

## 2) Predicate device II : DP-ZX-VL (Device Name: ROOT ZX II) (K071190)

The RCM-7 is substantially equivalent to the Canal Measurement Module of the DP-ZX-VL (K071190) from J.MORITA MFG.CORP. The RCM-7 has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device, DP-ZX-VL (K071190).

Although there are minor differences in the characteristics of the RCM-7 and its predicate devices, these differences do not raise new questions of safety or effectiveness.

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

| | Predicate devices | |
|-----------------------------------------------------|--------------------------------|-----------------------|
| TECHNOLOGICAL<br>CHARACTERISTICS of<br>RCM-7 | Root ZX (K921979<br>/ K953867) | DP-ZX-VL<br>(K071190) |
| Indication for use<br>Canal Measurement Function | Identical | Identical |
| Canal Preparation Function<br>Light Cure Function | | Different |
| Target population | Identical | Identical |
| Design | Similar | Similar |
| Materials | Similar | Similar |
| Performance<br>Canal Measurement Function | Identical | Identical |
| Canal Preparation Function<br>Light Cure Function | | Different |
| Sterility | Similar | Similar |
| Biocompatibility | Similar | Similar |
| Mechanical safety | Identical | Identical |
| Chemical safety | Identical | Identical |
| Anatomical sites | Identical | Similar |
| Human factors | Identical | Similar |
| Energy used and/or delivered | Identical | Similar |
| Compatibility with environment<br>and other devices | Similar | Similar |
| Where used | Identical | Identical |
| Standards met | Similar | Identical |
| Electrical safety | Similar | Identical |
| Thermal safety | Identical | Identical |

,

i

# 7. INDICATIONS FOR USE

RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

·

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

J. Morita USA. Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, Northwest, Suite 1100 Washington, D.C 20005

NOV 2 3 2009

Re: K090925 Trade/Device Name: Multiple (Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LOY Dated: November 16, 2009 Received: November 17, 2009

Dear Mr. Barritt:

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 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. Barritt

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours.

for

Susan Runner, D.D.S., M.A. Acting 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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# Indications for Use

999935

090925 510(k) Number (if known):

·

Multiple (Apex Locator) Device Name:

. Indications For Use: ......

RCM-7 is a dental device, Apex Locator.

It can be used to detect the apex of root canal.

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

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)

Rein Morley for MSE

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

K090925 510(k) Number:

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