ROOT ZX II

K071190 · J. Morita USA, Inc. · EKX · Aug 17, 2007 · Dental

Device Facts

• Record ID: K071190
• Device Name: ROOT ZX II
• Applicant: J. Morita USA, Inc.
• Product Code: EKX · Dental
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

DP-ZX-VL is a dental device, composed of a "Canal Measurement Module" and "Handpiece / LED Module". The former can measure the length of the root canal. The latter can enlarge the root canal while monitoring the position of the file tip inside the canal, and can be used to polymerize (set) resinous and other materials by light from the Light Cure Handpiece head.

Device Story

ROOT ZX II (DP-ZX-VL) is a dental device combining root canal measurement, canal preparation, and light-curing functions. It consists of a Canal Measurement Module and a Handpiece/LED Module. The measurement module determines root canal length; the handpiece module enables canal enlargement while providing real-time monitoring of the file tip position within the canal. The integrated LED head allows for polymerization of resinous materials. Used in dental clinics by dentists/dental professionals. The device provides visual feedback to the clinician regarding file tip location, assisting in accurate canal preparation and reducing the risk of over-instrumentation. The light-cure function facilitates the setting of restorative materials during the same procedure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Dental device comprising a Canal Measurement Module and Handpiece/LED Module. Functions include electronic root canal length measurement, motorized canal preparation, and LED-based light curing. Operates via electrical energy. Design, materials, and performance characteristics are identical or similar to predicates DP-ZX and VL-7. Sterilization, biocompatibility, and electrical/thermal safety profiles are consistent with established dental device standards.

Indications for Use

Indicated for dental patients requiring root canal length measurement, root canal enlargement (preparation) with real-time file tip monitoring, and light-curing of resinous dental materials.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• DP-ZX (K031204)
• VL-7 (K063529)

Submission Summary (Full Text)

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### 510(k) SUMMARY

# J. MORITA USA Inc.'s ROOT ZX II

# AUG 1 7 2007

### 1. NAME OF DEVICE

| Common/Usual Name: | Dental root canal measuring and treatment units |
|----------------------------|-------------------------------------------------|
| Trade or Proprietary Name: | ROOT ZX II |
| Product Model Name : | DP-ZX-VL |

#### 2. Submitter Name and Address with Phone/Fax :

| Registration No. 2081055 | Registration No. 3002807636 |
|--------------------------|-----------------------------|
| Initial Distributor: | Manufacturer: |
| J. Morita USA, Inc. | J. MORITA MFG. CORP. |
| 9 Mason | 680 Higashihama Minami-cho |
| Irvine, CA 92618 | Fushimi-ku, Kyoto |
| USA | Japan 612-8533 |
| Telephone: [phone] | [phone] |
| Facsimile: 949-581-9688 | [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]

4. Date summary prepared: April 24, 2007

# 5. DEVICE CLASSIFICATION/CLASSIFICATION PANEL

The DP-ZX-VL is classified as non-exempt Class II device, as Regulation Number (Regulation Name):

21 CFR § 872.4200(Dental handpiece and accessories) and

21 CFR § 872.6070 (Ultraviolet activator for polymerization).

Regulatory Class : प Product Code: EKX, LQY and EBZ

Classification Panel: 872 Dental.

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#### 6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE

#### DEVICE DESCRIPTION

The DP-ZX-VL is a dental device, built up simply by adding the same function as VL-7 (K063529) to the DP-ZX (K031204) . There are almost no new differences created in functions and structures.

The DP-ZX-VL is composed of a Canal Measurement Module and a Handpiece / LED Module.

The Canal Measurement Module can be used alone and has root canal measurement capability.

The Handpiece / LED Module can be used only when it is connected with the Canal Measurement Module. When it is connected, it has root canal measurement, canalpreparation and light cure functions.

The Canal Measurement and the Canal Preparation functions of the DP-ZX-VL are substantially equivalent to the functions of the DP-ZX (K031204). The Light Cure function of DP-ZX-VL is the additional function to the DP-ZX (K031204).

#### SUBSTANTIAL EQUIVALENCE

The DP-ZX-VL is substantially equivalent to other legally marketed devices.

#### 1) Predicate device I : DP-ZX(K031204)

The Canal Measurement and Canal Preparation function of the DP-ZX-VL is substantially equivalent to those functions of the DP-ZX(K031204) from J.MORITA MFG.CORP. The DP-ZX-VL has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device. DP-ZX (K031204).

#### 2) Predicate device II : VL-7 (K063529)

The Light Cure Function of the DP-ZX-VL is substantially equivalent to the function of VL-7 (K063529) from J.MORITA MFG.CORP. The DP-ZX-VL has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device. VL-7.

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

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| | Predicate device | |
|--------------------------------------------------------------------------------|------------------|----------------|
| TECHNOLOGICAL<br>CHARACTERISTICS of DP-ZX-VL | DP-ZX (K031204) | VL-7 (K063529) |
| Indication for use<br>Canal Measurement Function<br>Canal Preparation Function | Identical | |
| Light Cure Function | | Identical |
| Target population | Identical | Identical |
| Design | Identical | Similar |
| Materials | Identical | Identical |
| Performance<br>Canal Measurement Function<br>Canal Preparation Function | Similar | |
| Light Cure Function | | Similar |
| Sterility | Identical | Identical |
| Biocompatibility | Identical | Identical |
| Mechanical safety | Identical | Identical |
| Chemical safety | Identical | Identical |
| Anatomical sites | Similar | Similar |
| Human factors | Similar | Similar |
| Energy used and/or delivered | Similar | Similar |
| Compatibility with environment<br>and other devices | Similar | Similar |
| Where used | Identical | Identical |
| Standards met | Identical | Identical |
| Electrical safety | Identical | Identical |
| Thermal safety | Identical | Identical |

## Table- 1 Comparison summary table

### 7. Indications for Use

DP-ZX-VL is a dental device, composed of a "Canal Measurement Module" and "Handpiece / LED Module".

The former can measure the length of the root canal.

The latter can enlarge the root canal while monitoring the position of the file tip inside the canal, and can be used to polymerize (set) resinous and other materials by light from the Light Cure Handpiece head.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 17 2007

Re: K071190

Trade/Device Name: DP-ZX-VL is a Dental Device, Composed of a "Canal Measurement Module" and "Handpiece / LED Module" Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ, LQY, EKX Dated: August 14, 2007 Received: August 15, 2007

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 such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Chiu Lin, Ph.D.

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

510(k) Number (if known): unknown

Device Name: ROOT ZX II

. Indications For Use:

DP-ZX-VL is a dental device, composed of a "Canal Measurement Module" and "Handpiece / LED Module".

The former can measure the length of the root canal. The latter can enlarge the root canal while monitoring the position of the file tip inside the canal, and can be used to polymerize (set) resinous and other materials by light from the Light Cure Handpiece head.

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) | |
|--------------------------------------------------------|--|
| | |

Susan Runye

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

610(k) Number ..

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