(127 days)
K#022147
Not Found
No
The summary describes a device for measuring and enlarging root canals using an electric motor and length measurement, with no mention of AI or ML terms or functionalities.
Yes
The device is used for treatment (enlarging the canal) and measurement related to root canals, which falls under therapeutic intervention.
Yes
The device measures the length of the root canal and monitors the position of a file tip inside the canal, which provides information about the patient's anatomical status (root canal length and file tip position).
No
The device description explicitly states it is a "low-voltage electric motor and root canal length measuring device," indicating it includes hardware components beyond just software.
Based on the provided information, the DENTAPORT ZX is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- DENTAPORT ZX Function: The DENTAPORT ZX is a device used directly on the patient's tooth (specifically, the root canal) to measure length and enlarge the canal. It does not analyze samples taken from the body.
Therefore, the DENTAPORT ZX falls under the category of a medical device used for treatment and measurement within the body, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The DENTAPORT ZX is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
Product codes
EKX, LQY
Device Description
The DENTAPORT ZX is a low-voltage electric motor and root canal length measuring device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#022147
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 DENTAPORT ZX Dental Device
Name of Device and Name/Address of Sponsor
| Trade or Proprietary Name: | DENTAPORT ZX |
|---|---|
| Common Name: | dental handpiece and root canal length measuring device |
| Classification Name: | AC-Powered Dental Handpiece and Root Apex Locator |
| Product Code: | EKX and LQY |
J. Morita USA, Inc. 9 Mason Irvine, California USA 92618 949-581-9600 Telephone: Facsimile: 949-581-9688 Contact Person: Mr. Junichi Miyata, President Date Prepared: June 25, 2002
Intended Use
The DENTAPORT ZX is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
Technological Characteristics and Substantial Equivalence
The DENTAPORT ZX is a low-voltage electric motor and root canal length measuring device. The DENTAPORT ZX covered by this submission is identical in every respect to the DENTA PORT device already authorized by the FDA under K#022147. The only difference is a change in the instructions for use regarding the sterilization of the device.
The new sterilization parameters have been properly validated and result in a sterility assurance level of at least 106. Thus, the changes in sterilization parameters do not raise any new questions of safety or efficacy.
40148758.doc
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of an eagle with three lines representing its wings and head. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2003
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt 1425 K Street, N.W. Fish & Richardson P.C. 11th Floor Washington, DC 20005
Re: K031204
Trade/Device Name: Dentaport ZX Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX, LQY Dated: May 15, 2003 Received: May 30, 2003
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Ranger
Susan Runner, DDS MA, Interim 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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U.S. Food and Drug Administration - Center for Devices and Radiological Health
Page 1 of 1
510(k) Number (if known):
Device Name: DENTAPORT ZX
Indications for Use:
The DENTAPORT ZX is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
Kein Marley sa RSN
Division of Anasthacinlo ontrol Denta
510(k) Number: K031204
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
40148770.doc