(109 days)
Not Found
No
The summary describes a dental device for root canal measurement, preparation, and light curing, and explicitly states there are "almost no new differences created in functions and structures" compared to predicate devices. There is no mention of AI, ML, image processing, or any data-driven learning components.
Yes
The device performs therapeutic functions such as enlarging the root canal and polymerizing resinous materials by light, which are actions intended to treat or alleviate a condition.
Yes
The "Canal Measurement Module" measures the length of the root canal and monitors the position of the file tip, which are diagnostic functions as they provide information about the patient's anatomical status.
No
The device description explicitly states it is composed of a "Canal Measurement Module" and "Handpiece / LED Module," which are physical hardware components. It also describes functions like root canal measurement, canal preparation, and light curing, which are performed by these hardware modules.
Based on the provided information, the DP-ZX-VL is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DP-ZX-VL Function: The DP-ZX-VL is a dental device used for:
- Measuring the length of the root canal (an in-situ measurement).
- Enlarging the root canal (a procedural function).
- Polymerizing dental materials (a procedural function).
These functions are performed directly on the patient's tooth and do not involve the analysis of specimens taken from the body. Therefore, it does not fit the definition of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EKX, LQY, EBZ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DP-ZX(K031204), VL-7 (K063529)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
| Predicate device | ||
|---|---|---|
| TECHNOLOGICAL | ||
| CHARACTERISTICS of DP-ZX-VL | DP-ZX (K031204) | VL-7 (K063529) |
| Indication for use | ||
| Canal Measurement Function | ||
| Canal Preparation Function | Identical | |
| Light Cure Function | Identical | |
| Target population | Identical | Identical |
| Design | Identical | Similar |
| Materials | Identical | Identical |
| Performance | ||
| Canal Measurement Function | ||
| 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 | ||
| 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.
3
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
5
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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