HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE

K080682 · Handpiece Headquarters, Inc. - Hpr, Inc. · EFB · Sep 11, 2008 · Dental

Device Facts

• Record ID: K080682
• Device Name: HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
• Applicant: Handpiece Headquarters, Inc. - Hpr, Inc.
• Product Code: EFB · Dental
• Decision Date: Sep 11, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This Handpiece is used by authorized persons in the practice of dentistry. This Handpiece is intended for removing carious material, reducing hard tooth structures, cavity preparations, finishing tooth preparations, restorations and polishing teeth.

Device Story

Air-powered dental handpiece; includes turbine (push-button or screw-type). Operates via high-pressure air impacting impeller blade pockets; causes turbine rotation at high speed. Dental cutting bur connects to turbine spindle; rotates at same speed as impeller. Cooling water flows through inlet tube at high pressure; exits near bur to reduce cutting area temperature. Used by dentists/authorized personnel in clinical settings for tooth preparation and restoration. Provides mechanical cutting/polishing action to assist in dental procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and functional comparison to predicate devices.

Technological Characteristics

Air-powered dental handpiece; 4-hole configuration. Features air-driven turbine (impeller) and water cooling system. Materials include standard dental handpiece components. Operates via pneumatic energy source. Non-electronic, mechanical device.

Indications for Use

Indicated for use by dental professionals for removal of carious material, cavity preparation, finishing of tooth preparations, reduction of hard tooth structures, restorations, and tooth polishing.

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

• SUPER-AIR S (K062947)
• SUPER-AIR U (K062947)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K080682". The writing is in black ink on a white background. The characters are somewhat stylized and connected.

Image /page/0/Picture/1 description: The image shows the logo for "Handpiece Headquarters". The text is in a bold, sans-serif font, with the word "Handpiece" stacked on top of the word "Headquarters". There is a line below the text, and some other text below the line, but it is too small to read. The logo is black and white.

#### 510(K) SUMMARY:

# SEP 1 1 2008

### AIR-POWERED HANDPIECE MODELS: HENRY SCHEIN/ HHC/ SCORE Canister Handpiece. (Identical Handpiece/ 3 difference labels) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

| 510K | |
|---------------------------------------------------------------------|-------------------------------------------------------|
| a- Submitted by: | HANDPIECE HEADQUARTERS |
| | 2284 N. GLASSELL ST. UNIT A. ORANGE, CA.92865 |
| | Tel. [phone] Fax. [phone] |
| b- Contact person: | Tina Steffanie-Oak |
| | Tel. [phone], ext. 4150 Fax. [phone] |
| | Email: [e-mail] |
| c- Date summary prepared: | 03/06/08 |
| d- Device Name: | |
| Trade or Proprietary Name: | HENRY SCHEIN Canister Handpiece |
| Common Name: | Air-Power Dental Handpiece |
| Classification Name: | Dental Handpiece and accessories |
| | (21CFR 872.4200) |
| | Class: I |
| Product Code: | EFB "Handpiece, Air-powered, Dental" |
| e- Substantial Equivalency is claimed against the following device: | |
| | SUPER-AIR S: Standard, 400,000 rpm, Wrench Type Chuck |
| | SUPER-AIR: Standard, 400,000 rpm, push button chuck. |
| | Products of Peng Lim Enterprise Co., Ltd. (K062947) |
| f- Description of the device: | |

f- Description of the device:

The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's sharik (spindle),

. . . .

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which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

#### g- Statement of Intended Use:

This Handpiece is used by authorized persons in the practice of dentistry.

This Handpiece is intended for removing carious material, reducing hard tooth structures, cavity preparations, finishing tooth preparations, restorations and polishing teeth.

h- Safety and effectiveness of the device:

The canister handpiece is as safe and effective as the predicate device as cited above.

#### I – Conclusion:

Based on the information in the notification Handpiece Headquarters believes that this Canister Handpiece is substantially equivalent to the claimed predicate device. ( SUPER-AIR S & SUPER-AIR U Handpiece Models manufacture by PENG LIM ENTERPRISE CO., Ltd.)

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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

SEP 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina Steffanie-Oak Senior Regulatory Specialist Handpiece Headquaters Incorporated 2284 North Glassell Street, Unit A Orange, California 92856

Re: K080682

Trade/Device Name: Henry Schein Canister Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Codc: EFB Dated: September 9, 2008 Received: September 10, 2008

Dear Ms. Steffanie-Oak:

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. Steffanie-Oak

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.

V.H. Arnold's Penders. foell

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

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510(k) Number (if known): K080682

Device Name: Henry Schein Canister Handpiece

Indications for Use:

The Dental Handpiece is used by authorized persons in the practice of dentistry.

This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

AND/OR Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

Over-The-Counter Use

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Pearson

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

510(k) Number: K080682