JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU

K062740 · Jindell Medical Instruments Co., Ltd. · EFB · Nov 2, 2006 · Dental

Device Facts

• Record ID: K062740
• Device Name: JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
• Applicant: Jindell Medical Instruments Co., Ltd.
• Product Code: EFB · Dental
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The JINDELL High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Device Story

Air-powered dental handpiece; utilizes compressed air to drive internal turbine for high-speed rotation of dental burs. Used by licensed dental professionals in clinical settings for tooth structure removal, cavity preparation, and polishing. Device functions as mechanical tool for dental restorative procedures; provides precision control for clinician during operative dentistry. Benefits patient by enabling efficient removal of decay and preparation of teeth for restorations.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench-level comparisons of intended use and device characteristics.

Technological Characteristics

High-speed air turbine dental handpiece. Powered by compressed air. Models: SW, SP, SU, ETU, MU. Class I medical device (21 CFR 872.4200).

Indications for Use

Indicated for dental procedures including removal of carious material, reduction of hard tooth structure, cavity preparation, finishing of preparations and restorations, and tooth polishing. Restricted to use by licensed dental professionals.

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

• TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 (K052822)

Submission Summary (Full Text)

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JINDELL
JINDELL MEDICAL INSTRUMENTS CO.,LTD

MEDICAL INSTRUME

K062740

## 5. 510(K) SUMMARY

JINDELL High Speed Air Turbine Handpiece Models: SW, SP, SU, ETU, MU

NOV - 2 2006

510K:

| Submitted by: | JINDELL MEDICAL INSTRUMENTS CO., LTD.<br>No. 6-1, Alley 51, Lane 607, Rueilong Rd., Cianjhen<br>Dist., 80642, Kaohsiung City, Taiwan, ROC |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Jen, Ke-Min<br>No.58, Fu-Chiun Street, Hsin-Chu City,Taiwan, ROC<br>Tel: [phone] fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | September 9, 2006 |
| Name of the Device: | Dental Air-Powered Handpiece |
| Classification: | Dental Air-Powered Handpiece ( class I medical<br>device; 21 CFR 872.4200 )<br>Product code: EFB<br>Panel: 72 |
| ● Predicate Device: | Dental Air-Powered Handpiece,<br>models: TIGER 100, TIGER 101, TIGER 200,<br>TIGER 201, TIGER 202<br>510K No -K052822 |
| ● Statement of Intended Use: | The JINDELL High Speed Air Turbine |

Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

> CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

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Image /page/1/Picture/0 description: The image shows the logo and contact information for JINDELL MEDICAL INSTRUMENTS CO., LTD. The address is No.6-1, Alley 51, Lane 507, Ruilong Rd., Cianjhen District, Kaohsiung City 80642, Taiwan. The telephone number is [phone], and the fax number is [phone]. The email address is [e-mail], and the website is http://www.taiwantrade.com.tw/inde.

- Performance Data: The claim of substantial equivalence is based on . comparisons of formulations and intended uses of the JINDELL High Speed Air Turbine Handpiece and its claimed predicate.
- Conclusion: Based on the information in the notification, JINDELL Medical ● Instruments Co., Ltd. believes that High Speed Air Turbine Handpieces are substantially equivalent to the claimed predicate, i.e., Dental Air-Powered Handpiece, models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202, (K052822).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jindell Medical Instruments Company, Limited C/O Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No.58, Fu-Chiun Street Hsin-Chu City China (TAIWAN) 30067

NOV - 2 2006

Re: K062740

Trade/Device Name: JINDELL High Speed Air Turbine Handpiece, Models: SW, SP, SU, ETU, MU Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 9, 2006 Received: September 13, 2006

Dear Dr. Jen:

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 - Dr. Jen

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 [phone]. 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 [phone] or [phone] 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 ):

Device Name: JJNDELL High Speed Air Turbine Handpiece,

Models: SW, SP, SU, ETU, MU

Indications for Use :

- JINDELL High Speed Air Turbine Handpiece, models: SW, SP, SU, ETU, MU are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- · JINDELL High Speed Air Turbine Handpiece carries the following label:

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suxes Garne

Anesthesiology, General Hospal,
An Control, Dental Devices

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