(162 days)
Not Found
No
The description focuses on the mechanical operation of the device using air, water, and powder, with no mention of AI/ML terms or functionalities.
No
The device is used for cleaning (removing plaque, stain, and discoloration) and not to treat a disease or condition.
No
Explanation: The device is described as removing "dental plaque, stain, and discoloration from tooth surface," which is a treatment or prophylactic function, not a diagnostic one.
No
The device description clearly outlines a physical device that connects to a dental unit and uses air, water, and powder to remove plaque. This involves hardware components and mechanical action, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove dental plaque, stain, and discoloration from tooth surface" during dental treatment. This is a physical process performed directly on the patient's teeth.
- Device Description: The device uses air, water, and powder to physically clean the tooth surface. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices (e.g., reagents, assays, analysis of biomarkers).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely mechanical and therapeutic (cleaning), not diagnostic.
N/A
Intended Use / Indications for Use
The proposed device is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.
The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
Both the predicate and the new proposed devices are operated by connecting to a standard turbine connection of a dental unit, which supplies air and water. The device is activated when the dental unit is activated and compressed air and water are supplied to the device. Air enters into the powder chamber where it is mixed with the prophylaxis powder. The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
The proposed device was designed and tested according to the applicable international standards and specifications developed by the manufacturer. No clinical tests were performed for the proposed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
K 133170
Micron Corporation, 510(k) Summary
5.510(k) Summary
5.1 SPONSOR / SUBMITTER
a. Company name: MICRON Corporation
- b. Address: 1-34-14, Higashiyukigaya, Ota-ku, Tokyo, 145-0065, Japan
- c. Contact person: Takashi Terui (Mr.)
- d. Phone number: +81-3-3755-0396
- f. Fax number: +81-3-5747-5396
- g. E-mail address: office@micdent.com
Date Prepared
11/08/2013
- 510(k) Number: K133170
5.2 DEVICE NAME
Trade/Proprietary Name:
QUICK JET M
Device Classification / Classification Panel
- a. Common / Usual Name: Dental Handpiece
- b. Classification Name: Dental Handpiece and Accessories
- c. Regulation Number: 21 CFR 872.4200
- d. Regulatory Class: I
- e. Product Code: EFB
5.3 PREDICATE DEVICE
| Name of the Manufacturer
or Specification developer | Product name | 510(k) Number | Classification
Product Code | Classification Name |
|--------------------------------------------------------|------------------|---------------|--------------------------------|-------------------------------------|
| E.M.S. Electro Medical
Systems S.A. | AIR-FLOW handy 2 | K022119 | EFB | Dental handpiece
and Accessories |
5.4 DEVICE DESCRIPTION AND INTENDED USE
Device Description
Both the predicate and the new proposed devices are operated by connecting to a standard turbine
connection of a dental unit, which supplies air and water. The device is activated when the
dental unit is activated and compressed air and water are supplied to the device.
Air enters into the powder chamber where it is mixed with the prophylaxis powder.
1
Micron Corporation, 510(k) Summary
The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.
Intended Use
The proposed device is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment
| Technological Characteristics of Handpiece | Comparison result |
|---|---|
| AIR-FLOW handy 2 | |
| intended use | Slimilar |
| Indication for use | Identical |
| Target population | Identical |
| Anatomical safety | Identical |
| Where used(hospital, home, ambulance, etc) | Identical |
| Engery used and/or delivered | Identical |
| Human factors | Identical |
| Design | Slimilar |
| Performance | Slimilar |
| Standards met | Unknown |
| Materials | Slimilar |
| Biocompatibility | Unknown |
| Compatibility with environment and other devices | Identical |
| Sterility | Slimilar |
| Electrical safety | N/A |
| Mechanical safety | Identical |
| Chemical safety | Slimilar |
| Thermal safety | N/A |
| Radiation safety | N/A |
5.5 SUBSTANTIAL EQUIVALENCE
5.6 SUMMARY OF NON-CLINICAL TESTING
The proposed device was designed and tested according to the applicable international standards and specifications developed by the manufacturer.
2
Micron Corporation, 510(k) Summary
5.7 SUMMARY OF CLINICAL TESTING
No clinical tests were performed for the proposed device device.
5.8 CONCLUSION
The information above demonstrates that the proposed device is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure with outstretched arms, representing care and protection, overlaid with a stylized caduceus, a symbol of medicine and health.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
MICRON Corporation Mr. Takashi Terui 1-34-14, Higashiyukigaya OTA-Ku, Tokyo 145-0065 Japan
Re: K133170
Trade/Device Name: Quick Jet M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 26, 2013 Received: January 2, 2014
Dear Mr. Terui:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2 - Mr. Terui:
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Salcty/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mary S. Runner -S
Erin 1. Keith. M.S. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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): Not Assigned
Device Name: Quick Jet M
Indications for Use:
. 1
The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment..
Prescription Use _ X (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 Center for Devices and Radiological Health (CDRH)
4-1
Sheena A. Green-S
2014.03.28 13:03:22 -04'00'
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