IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE

K972375 · Glenwood, LLC · EFB · Sep 10, 1997 · Dental

Device Facts

• Record ID: K972375
• Device Name: IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
• Applicant: Glenwood, LLC
• Product Code: EFB · Dental
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used.

Device Story

Air-powered dental handpiece; used for apicoectomy and endodontic procedures. Input: compressed air from standard dental unit; output: high-speed rotation (400,000–500,000 rpm) of friction-grip burs. Features 45-degree back-angled head shank for improved access; air exhaust design prevents air from blowing directly onto bur area. Includes water line for cooling mist/irrigation; optional fiberoptic bundle for illumination. Operated by dental professionals in clinical settings. Benefits: improved access and work environment compared to conventional high-speed handpieces.

Clinical Evidence

Bench testing only. Data indicates the device functions appropriately after 250 autoclave sterilization cycles (35 minutes at 250 degrees).

Technological Characteristics

Air-powered turbine; 45-degree back-angled head; friction-grip bur compatibility (ISO/ADA shank diameter 0.0626–0.0630 inches). Operating pressure 32–40 psi; speed 400,000–500,000 rpm. Includes water irrigation line and optional fiberoptic illumination. Sterilization via autoclave.

Indications for Use

Indicated for use in apicoectomy (root canal drainage) and other endodontic procedures requiring a dental handpiece.

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

• Fiber Optic High Speed Handpiece (K760794)
• Tradition High Speed Handpiece (K863677)
• Dental Handpiece (K780038)
• W-H Topair Dental Handpiece (K912786)

Submission Summary (Full Text)

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K972375

## SEP I 0 1997

## 510 (K) SUMMARY

- I. Submitter :
Palisades Dental A Division of Glenwood, L.L.C. 82 N. Summit Street Tenafly, NJ 07670 Contact Person: Cynthia Romanoff Telephone: [phone]

- Date 510(k) Summary Prepared: June 20, 1997 II.
- Impact Air 45 Handpiece for Endodontic Use III. Trade Name:
- IV. Classification Name: Dental Handpiece (21 C.F.R. §872.4200)
- Predicate Devices: "Fiber Optic High Speed Handpiece" (K760794) V. and "Tradition High Speed Handpiece" (K863677), both manufactured by Midwest; the "Dental Handpiece" (K780038) by Lares Manufacturing Co.; and the "W-H Topair Dental Handpiece" (K912786) by Sabra.
- Device Description: The Impact Air 45 Handpiece for Endodontic VI. Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access.

The device is intended for use with all friction-grip burs, including surgical length burs, that conform to I.S.O. and A.D.A. shank diameter standards (0.0626 to 0.0630 inches). The recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"), which results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). The device includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. The use of sterile water is recommended. One model of the device also includes a fiberoptic bundle that directs light onto the working area.

The device may be connected to a standard compressed air source found in virtually all dental units. The use of filtered air is recommended. The air supply enters the device through a tube in the handle and turns the turbine, which is

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in the head of the device, thus spinning the bur. The air exits the device principally through an air exhaust tube in the handle. A smaller portion of the air exits through the top of the head of the device. Virtually no air exits from the front of the head into the area of the bur.

The Impact Air 45 can be sterilized by autoclave when processed for 35 minutes at 250 deqrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.

- VII. Substantial Equivalence: The Impact Air 45 is substantially equivalent to a number of conventional high-speed, air-powered dental handpieces including the "Fiber Optic High Speed Handpiece" (K760794) and "Tradition High Speed Handpiece" (K863677), both manufactured by Midwest; the "Dental Handpiece" (K780038) by Lares Manufacturing Co.; and the "W-H Topair Dental Handpiece" (K912786) by Sabra. Based on our familiarity with these devices, we have concluded that the Impact Air 45 has the same intended use, does not raise different questions of safety and effectiveness, and is fundamentally similar in operating principle, design, materials, energy source, and other characteristics.

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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 features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's name and national affiliation. The logo is simple, using only black and white, which gives it a clean and professional appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

Mr. John I. Gruen Member Glenwood, L.L.C. Glenwood-Palisades One New Enqland Avenue Piscataway, New Jersey 08855

K972375 Re: Impact Air 45 Handpiece for Endodontic Use Trade Name: Requlatory Class: I Product Code: EFB Dated: June 20, 1997 Received: June 25, 1997

Dear Mr. Gruen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Paqe 2 - Mr. Gruen

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

N. Alatrist

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

Device Name:

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1

Impact Air 45 Handpiece for Endodontic Use

Indications:

The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used.

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number .

**Prescription Use**
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)