K Number

Device Name

IMPACT AIR 45 4-HOLE

Manufacturer

PALISADES PHARMACEUTICS, INC.

Date Cleared

1996-08-06

(407 days)

Product Code

EFB

Regulation Number

872.4200

Intended Use

The Impact Air 45 Handpiece is an air-powered dental handpiece.

Device Description

The Impact Air 45 Handpiece is an air-powered dental handpiece. The handpiece has an angled head shank with a back angle of 45 degrees. It is intended for use with all friction-grip bur that conform to I.S.O. and A.D.A. 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. 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 in the head of the device, thus spinning the bur. The Impact air 45 can be sterilized by autoclave when processed for 35 minutes at 250 degrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description is for a mechanical dental handpiece and does not mention any computational or data-driven features.

Therapeutic

No
The device description states it is an "air-powered dental handpiece" used for spinning burs and producing a cooling mist, which are mechanical functions in dental procedures, not therapeutic ones.

Diagnostic

Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device is described as an air-powered dental handpiece used for procedures involving bur rotation, water irrigation, and optional lighting, which are all therapeutic or procedural functions, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly describes a physical, air-powered dental handpiece with mechanical components (turbine, bur, water line, fiberoptic bundle) and sterilization requirements, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device function: The Impact Air 45 Handpiece is a dental tool used for mechanical procedures within the mouth (drilling, cutting). It operates directly on the patient's tissues, not on samples taken from the patient.
Intended Use: The intended use describes it as an "air-powered dental handpiece," which is a surgical/procedural tool, not a diagnostic one.

The description clearly indicates it's a device used for dental procedures, not for analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Not Found

Product codes

Not Found

Device Description

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 in the head of the device, thus spinning the bur.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Midwest Quiet Air Handpiece

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.

Summary

AUG

K952927

ES PHARMACFUTICALS, INC ENTAL. Division of Palisades Pharmacenticals, Inc.

64 NOKTI STIMMIT STRILET • TINAFLY, NEW JERSEY 07670 • (201) 569-8502 • 1-(800) 237-9083 • FVX (201) 569-7110

510(K) SUMMARY

I. Submitter:
Palisades Dental A Division of Palisades Pharmaceuticals, Inc. 64 N. Summit Street Tenafly, NJ 07670 Contact Person: Cynthia Romanoff Phone: (201) 569-8502 Fax: (201) 569-7416
II. Date 510(k) Summary Prepared: August 1, 1996
III. Trade Name: Impact Air 45 Handpiece
IV. Classification Name: Dental Handpiece (21 C.F.R. 8872.4200)
V. Predicate Devices: Midwest Quiet Air Handpiece
VI. Device Description: The Impact Air 45 Handpiece is an air-powered dental handpiece. The handpiece has an angled head shank with a back angle of 45 degrees. It is intended for use with all friction-grip bur that conform to I.S.O. and A.D.A. 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. One model of the device also includes a fiberoptic bundle that directs light onto the working area.

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

VII. Substantial Equivalence: The Impact Air as compared with the predicate device has the same intended use, does not raise different questions of safety and effectiveness, and is fundamentally the same in operating principle, design, materials, energy source, and other characteristics. Like the predicate device, the Impact air 45 has principally stainless steel construction; is air-powered, with a high-speed turbine in the head of the device; attaches to a standard connection for compressed air found in most dental units; and is slim, lightweight and easy to manipulate.