VELOPEX AQUACUT FLUID ABRASION UNIT

K024105 · Velopex International, Inc. · KOJ · Oct 9, 2003 · Dental

Device Facts

• Record ID: K024105
• Device Name: VELOPEX AQUACUT FLUID ABRASION UNIT
• Applicant: Velopex International, Inc.
• Product Code: KOJ · Dental
• Decision Date: Oct 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOR PIT AND FISSURE SEALANTS. PREPARATION REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION. CLEANING, POLISHING AND STAIN REMOVAL,

Device Story

Velopex Aquacut is a fluid abrasion unit used in dental clinics by dental professionals. Device utilizes air-abrasion technology to deliver a stream of abrasive particles to tooth surfaces. Used for cavity preparation, composite removal, and surface cleaning/polishing. Operates via compressed air/gas to propel media; provides controlled material removal. Benefits include minimally invasive preparation and efficient surface cleaning. Healthcare providers use the device to prepare teeth for restorative procedures or to perform prophylaxis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Air-abrasion dental unit; utilizes compressed air/gas to propel abrasive media; class II device; product code KOJ; regulation 872.6080.

Indications for Use

Indicated for dental procedures including pit and fissure sealant preparation, composite removal and restoration, cavity preparation, and tooth cleaning, polishing, and stain removal.

Regulatory Classification

Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol is a stylized representation of a human figure, with three profiles merging into a single form, suggesting a sense of unity and collaboration.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

Mr. Anthony Urella Vice President, Sales & Marketing Velopex International, Incorporated 105 East 17th Street Saint Cloud, Florida 34769

Re: K024105

Trade/Device Name: Velopex Aquacut Fluid Abrasion Unit Regulation Number: 872.6080 Regulation Name: Airbrush Regulatory Class: II Product Code: KOJ Dated: August 26, 2003 Received: September 2, 2003

Dear Mr. Urella:

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 - Mr. Urella

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/dsma/dsmamain.html

Sincerely vours,

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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Page I of I

K024105 510(k) Number (if known):

I evice Nlame: AQUACUT

I idications For Use:

FOR PIT AND FISSURE SEALANTS. PREPARATION

REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION.

CLEANING, POLISHING AND STAIN REMOVAL,

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 17 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Ruass

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

**510(k) Number:** K024105