HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D

K071561 · Beijing North Pole Dental Handpiece Co., Ltd. · EFB · Oct 12, 2007 · Dental

Device Facts

• Record ID: K071561
• Device Name: HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
• Applicant: Beijing North Pole Dental Handpiece Co., Ltd.
• Product Code: EFB · Dental
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

Device Story

Air-powered hand-held dental handpiece; used by dental professionals for cavity preparation, tooth drilling, and grinding. Device connects to dental air supply; mechanical energy rotates burr for tooth structure removal. Used in clinical dental settings to facilitate restorative procedures. Benefits patient by enabling precise removal of carious material and preparation of tooth structure for restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air-powered dental handpiece; mechanical rotation principle; handheld form factor; intended for dental office use.

Indications for Use

Indicated for dental cavity preparation, tooth body treatment, drilling, and grinding in patients requiring dental restorations.

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

• PENG LIM High Speed Air Turbine Handpiece (K062947)

Submission Summary (Full Text)

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007 1 2 2007

Premarket Notification 510(k) Submission - 510(k) Summary Report No .:

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

1041561 The Assigned 510(k) Number is:

## 1. Applicant Device Information:

Device Trade/Proprietary Name: Multiple Brand Names Device Common Name: Handpiece, Air Powered, Dental Device Classification Name: Handpiece, Air Powered, Dental Review Panel: Dental Product Code: EFB Regulation Number: 872.4200 Device Class: I Intended Use:

This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

#### 2. Submitter Information:

#### Establishment Registration Name and Address:

Beijin North Pole Dental Handpiece Co., Ltd Standard Workshop, Area A Beijing Airport Industrial Zone Shunyi, Beijing, P.R.China

### Contact Person of the Submission:

Diana Hong Shanghai Mid-link Consulting Co., Ltd. 1441, 6th Avenue San Francisco, California 94122 U.S.A Email: [e-mail] Fax: [phone]

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Premarket Notification 510(k) Submission - 510(k) Summary Report No .:

#### 3. Predict Device

PENG LIM High Speed Air Turbine Handpiece

K Number: K062947

Product Code: EFB

### Intended Use:

The PENG LIM 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.

### Manufactured by

PENG LIM ENTERPRISE CO., LTD. 67 Hwa Rong Rd., 2nd F1., Ku Shan Dist. Kaohsiung, CHINA (TAIWAN) Tel: [phone]

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

#### Public Health Service

OCT 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Beijing North Pole Dental Handpiece Company, Limited C/O Ms. Diana Hong General Manger Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19 Lane 999, Zhongshan No. 2 Road (s) Shanghai 200030 CHINA

Re: K071561

Trade/Device Name: Hi-Speed Turbine Handipieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 17, 2007 Received: September 24, 2007

Dear Ms. Hong:

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 - Ms. Hong

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 (OS) 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,

Swer Runnes
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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Premarket Notification 510(k) Submission-Indications for Use Report No .: A20071028

## Indications for Use

1071561 510(k) Number:

Pending

Device Name: Hi-Speed Turbine Handpieces

Indications for Use:

This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susi Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: