QUICK JET M

K133170 · Micron Corp. · EFB · Mar 28, 2014 · Dental

Device Facts

• Record ID: K133170
• Device Name: QUICK JET M
• Applicant: Micron Corp.
• Product Code: EFB · Dental
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The proposed device is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.

Device Story

Quick Jet M is a dental handpiece used by dental professionals to remove plaque, stain, and discoloration from tooth surfaces. The device connects to a standard dental unit turbine connection, which supplies compressed air and water. Air enters a powder chamber, mixing with prophylaxis powder. This mixture exits through a spraying nozzle, where it is enveloped by a water spray and directed onto the tooth surface. The device operates mechanically via air/water pressure; it does not involve electronic or software-based processing. It is used in a clinical setting to assist in dental hygiene and treatment.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Dental handpiece; pneumatic operation (air/water/powder mixture); connects to standard dental unit turbine; mechanical delivery system; no electrical components; no software.

Indications for Use

Indicated for removal of dental plaque, stain, and discoloration from tooth surfaces by dental professionals during dental treatment.

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

• AIR-FLOW handy 2 (K022119)

Submission Summary (Full Text)

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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: [phone]
- f. Fax number: [phone]
- g. E-mail address: [e-mail]

### 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<br>or Specification developer | Product name | 510(k) Number | Classification<br>Product Code | Classification Name |
|--------------------------------------------------------|------------------|---------------|--------------------------------|-------------------------------------|
| E.M.S. Electro Medical<br>Systems S.A. | AIR-FLOW handy 2 | K022119 | EFB | Dental handpiece<br>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.

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## 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.

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# 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.

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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K133170

# 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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