DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202

K052822 · Thunder Tiger Corp. · EFB · Jan 20, 2006 · Dental

Device Facts

• Record ID: K052822
• Device Name: DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
• Applicant: Thunder Tiger Corp.
• Product Code: EFB · Dental
• Decision Date: Jan 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Indications for 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 100, 101, 200, 201, 202) used by licensed dental professionals in clinical settings. Device utilizes compressed air to power a rotary instrument for tooth structure removal, cavity preparation, and polishing. Operates as a standard dental handpiece; provides mechanical action for restorative dentistry. Benefits include efficient removal of carious material and preparation of tooth surfaces for restorations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance data and comparison of intended use and design to the predicate device.

Technological Characteristics

Air-powered dental handpiece; mechanical rotary operation; 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 polishing of teeth in patients requiring dental care. Restricted to use by licensed 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

• CODENT Dental Air-Powered Handpiece, model HPS (K033213)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it on the left. To the right of the circle, the words "Thunder Tiger" are written in a bold, stylized font, with "Thunder" on top of "Tiger".

THI NDER TIGER CORP. No 7, 64 Road, industry park. Taching Tancan ROR' 407 Tel. [phone] - Fax. [phone] http://www.thunderinger.com E-mail the thundertiges com

K052822

JAN

## 5. 510(K) SUMMARY

CONDENT Dental Air-Powered Handpiece Models: HPS

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 device; 21 CFR 872.4200 )<br>Product code: EFB<br>Panel: 72 |
| Predicate Device: | CODENT Dental Air-Powered Handpiece,<br>model: HPS<br>510K No - K033213 |
| Statement of 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.<br>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 for Thunder Tiger. The logo consists of a circle with an airplane in the middle on the left side. To the right of the circle, the words "Thunder Tiger" are written in a stylized font, with "Thunder" on top and "Tiger" on the bottom.

NDER TIGER CORP. 2 Road milusiry park 2 Tarvan, ROK 407 cl. 886-4-23591616 - Fax. [phone] Formad 11 millingerifger com hip www.thouderinger.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. Conclusion:

Based on the information in the notification THUNDER TIGER believes that Dental Air-Powered Handpiece HPS is substantially equivalent to the claimed predicate, i.c., CODENT Dental Air-Powered Handpiece, (K033213)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

JAN 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thunder Tiger Corporation C/O Dr. Ke-Min Jen Official Correspondent ROC Chinese-European Industrial Research Society 58 Fu-Chiun Street Hsin Chu City, Taiwan 300

Re: K052822

Trade/Device Name: Dental Air-Powered Handpiece, Models TIGER 100, TIGER101, TIGER 200, TIGER 201, TIGER 202 Regulation Number: 872.4200 Regulation Name: Dental Handpicce and Accessories Regulatory Class: 1 Product Code: EFB Dated: December 20, 2005 Received: December 28, 2005

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to review your end have determined the device is substantially equivalent (for the referented a o re as a ted in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act rood Cosmetic Act (Act) that do not require approval of a premarket the Federal PUCA). You may, therefore, market the device, subject to the general appeared with of the Act. The general controls provisions of the Act include controls providents of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wrl), it hay be budyout is and Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Dr. Chai

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements moun that I Dr. mas Federal statutes and regulations administered by other Federal agencies. or the For any 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 and listing (2) es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as better in 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) Fins feter wiffication. 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), rr you 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,

Qure

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 an airplane inside of it, followed by the words "Thunder Tiger" stacked on top of each other. The text is in a bold, sans-serif font.

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## Indications for Use

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

. Device Namc: Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202

## Indications for Use :

- . THUNDER TIGER Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 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:

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 CDRII, Office of Device Evaluation (ODE)

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K052872
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