Who is the manufacturer of IMPACT AIR 45 4-HOLE?

Palisades Pharmaceutics, Inc. filed the 510(k) submission for IMPACT AIR 45 4-HOLE (K952927).

What is the FDA product code for IMPACT AIR 45 4-HOLE?

EFB. It is classified under 21 CFR 872.4200 as a Class 1 device in the Dental panel.

What is the regulatory pathway for IMPACT AIR 45 4-HOLE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IMPACT AIR 45 4-HOLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IMPACT AIR 45 4-HOLE

K952927 · Palisades Pharmaceutics, Inc. · EFB · Aug 6, 1996 · Dental

Device Facts

Record ID	K952927
Device Name	IMPACT AIR 45 4-HOLE
Applicant	Palisades Pharmaceutics, Inc.
Product Code	EFB · Dental
Decision Date	Aug 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4200
Device Class	Class 1

Intended Use

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.

Device Story

Air-powered dental handpiece; 45-degree angled head shank; utilizes friction-grip burs. Operates via compressed air (32-40 psi) driving a turbine in the head; achieves 400,000-500,000 rpm. Includes integrated water line for cooling mist/irrigation; optional fiberoptic bundle for illumination. Used by dentists in clinical settings; connects to standard dental unit air supply. Provides high-speed rotation for dental cutting/preparation; cooling mist minimizes thermal damage to tooth structure; fiberoptics improve visibility. Sterilizable via autoclave.

Clinical Evidence

Bench testing only. Data indicates device functions appropriately after 250 autoclave sterilization cycles.

Technological Characteristics

Stainless steel construction; air-powered turbine; 45-degree head angle; 32-40 psi operating pressure; 400,000-500,000 rpm; water irrigation system; optional fiberoptic illumination; compatible with standard dental unit air connections; autoclavable (250 degrees for 35 minutes).

Indications for Use

Indicated for use in dental procedures requiring high-speed bur rotation for cutting or removal of tooth structure.

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

Midwest Quiet Air Handpiece

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Submission Summary (Full Text)

{0} FROM : GLENWOOD-PALISADES PHONE NO. : 908 981 9790 Aug. 02 1996 11:14AM P2 AUG 6 1996 K952927 PALISADES PHARMACEUTICALS, INC. PALISADES DENTAL, Division of Palisades Pharmaceuticals, Inc. P.O. BOX 579 • 64 NORTH SUMMIT STREET • TENAFLY, NEW JERSEY 07670 • (201) 569-8502 • 1-(800) 237-9083 • FAX (201) 569-7416 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. §872.4200) 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 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. {1} F-3M : GLENWOOD-PALISADES PHONE NO. : 908 981 9790 Aug. 02 1996 11:14AM P3 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.