DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N

K062812 · Thunder Tiger Corp. · EFB · Nov 28, 2006 · Dental

Device Facts

• Record ID: K062812
• Device Name: DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
• Applicant: Thunder Tiger Corp.
• Product Code: EFB · Dental
• Decision Date: Nov 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The THUNDER TIGER Dental Air-Powered Handpiece is 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

Dental air-powered handpiece (models TIGER 300T, 300K, 300W, 300B, 300N) used by licensed dental professionals in clinical settings. Device utilizes compressed air to power a rotary instrument for mechanical removal of carious material, tooth structure reduction, cavity preparation, and polishing. Output is mechanical rotation of dental burs or polishing tools. Enables precise dental tissue modification and restoration finishing. Benefits patient by facilitating restorative dental procedures.

Clinical Evidence

No clinical data. Substantial equivalence is based on performance data comparisons of formulations and intended uses.

Technological Characteristics

Air-powered dental handpiece; mechanical rotary actuation; intended for use with dental burs/tools; 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. For use by licensed dental professionals only.

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

• Dental Air-Powered Handpiece, Model: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 (K052822)

Submission Summary (Full Text)

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TH NDER TIGER CORP. No 7, 64 Road, industry park, Laching, Faiwan, ROC' 407 Tel: [phone] - Fax: [phone] E-mail: tratthundertiget com - Imp/Avww.thouderligen.com

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NOV 2 8 2006

## 5. 510(K) SUMMARY

Dental Air-Powered Handpiece,_

models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N

| 510K: | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | THUNGER TIGER CORP.<br>No.7, 6th Road, Industry Park, Taichung, 407,<br>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 23, 2005 |
| 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>Model: TIGER 100, TIGER 101, TIGER 200,<br>TIGER 201, TIGER 202<br>510K No – K052822 |
| Statement of Intended Use: | The THUNDER TIGER Dental Air-Powered Handpiece<br>is intended for removing carious material, reducing<br>hard tooth structure, cavity preparation, finishing tooth<br>preparations and restorations and polishing teeth.<br>⚠ CAUTION: Federal (US) law restricts the use of<br>this device to licensed professionals. |

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Image /page/1/Picture/0 description: The image shows a logo for Thunder Tiger. The logo consists of a circle with an airplane in the center, and the words "Thunder Tiger" are written to the right of the circle. The words are stacked on top of each other, with "Thunder" on top and "Tiger" on the bottom.

FILENDER TICER CORP. Vo 7, 6" Road, industry park. Fachung, Fanvan, ROC' 407 Tcl. 886-4-23591616 - Fax: [phone] E-mail (Pashmascriger com http://www.thouderliger.com

The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the THUNDER TIGER Dental Air-Powered Handpiece and its claimed predicate. Based on the information in the notification THUNDER Conclusion: TIGER believes that Dental Air-Powered Handpiece HPS is substantially equivalent to the claimed predicate,

THUNDER TIGER Dental Air-Powered i.e., Handpiece Model: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 (K052822)

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 28 2006

Thunder Tiger Corporation C/O Mr. Jen Ke-Min ROC Chinese-European Industrial Research 58 Fu-Chiun Street Hsin Chu City, CHINA (Taiwan) 300

Re: K062812

Trade/Device Name: Dental Air-Powdered Handpiece, Models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: 1 Product Code: EFB Dated: September 16, 2006 Received: September 19, 2006

Dear Mr. Ke-Min:

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, thereforc, 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. Ke-Min

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,

Sisa Qunar

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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Image /page/4/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with a four-pointed star inside, and the words "Thunder Tiger" written in a stylized font to the right of the circle. The word "Thunder" is written above the word "Tiger". The logo is black and white.

Fax: [phone] Inn Steren thanderliger com 1993 masentier com

## Indications for Use

KCOA 510 (K) Number ( If Known ):

● Dental Air-Powered Handpiece, models TIGER 300T, Device Name: TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N,

## Indications for Use :

- · THUNDER TIGER Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- · THUNDER TIGER Dental Air-Powered Handpiece carries the following label: 1\ 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)

Susa Caser

Tura saklogy, General Hospi
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Con bental Devices

K06282

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