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 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).

AI/ML Overview

The provided text is a 510(k) summary for the J. Morita USA Inc.'s ROOT ZX II (DP-ZX-VL) device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document primarily focuses on establishing "substantial equivalence" to previously cleared devices (DP-ZX and VL-7) based on similar indications for use, principles of operation, and technological characteristics. The performance section in the comparison table only states "Similar" for the Canal Measurement Function and Light Cure Function, without providing quantitative data or thresholds.

Therefore, I cannot populate the requested table and details regarding acceptance criteria and performance study from the given text. The information required for those points is not present in this 510(k) summary.

Here's a breakdown of what is and is not in the provided text, related to your request:

What is present (or can be inferred):

Device Name: ROOT ZX II (DP-ZX-VL)
Intended Use:
- Canal Measurement Module: measure the length of the root canal.
- Handpiece / LED Module: enlarge the root canal while monitoring the position of the file tip inside the canal, and polymerize (set) resinous and other materials by light.
Comparison to Predicate Devices: The device is considered "substantially equivalent" to DP-ZX (K031204) for canal measurement and preparation, and to VL-7 (K063529) for light cure function. This implies that the performance of the new device is presumed to be similar to these already cleared devices, but no new performance study data is provided to prove this for the new device.

What is NOT present in the document:

Table of Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., accuracy, precision, error margins) or thresholds are defined as acceptance criteria, nor is there a table reporting the device's measured performance against hypothetical criteria.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or how training ground truth was established: None of this information is available. The document refers to "Performance" as "Similar" to predicate devices, indicating that no new, independent performance study was conducted and detailed in this submission. The 510(k) pathway often relies on demonstrating equivalence rather than requiring extensive new clinical performance studies if technological characteristics and intended use are sufficiently similar to predicate devices.

Summary

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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: 949-581-9600	+81-75-611-2141
Facsimile: 949-581-9688	+81-75-605-2354

3. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331

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.

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
TECHNOLOGICALCHARACTERISTICS of DP-ZX-VL	DP-ZX (K031204)	VL-7 (K063529)
Indication for useCanal Measurement FunctionCanal Preparation Function	Identical
Light Cure Function		Identical
Target population	Identical	Identical
Design	Identical	Similar
Materials	Identical	Identical
PerformanceCanal Measurement FunctionCanal 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 environmentand 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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".

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 ..

Page 1 of

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.