COMPACT PLUS - EXTREME - PERFECT PLUS

K052574 · J.O. Suarez & Cia, Ltda · EIA · Jul 17, 2006 · Dental

Device Facts

• Record ID: K052574
• Device Name: COMPACT PLUS - EXTREME - PERFECT PLUS
• Applicant: J.O. Suarez & Cia, Ltda
• Product Code: EIA · Dental
• Decision Date: Jul 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.

Device Story

Compact Plus, Perfect Plus, and Extreme Operative Dental Units are AC-powered dental chairs with integrated operative units. Device serves as a mechanical base/platform for mounting auxiliary dental equipment, including handpieces and air/water syringes. Operated by dentists in clinical settings to position patients for routine dental procedures. Device does not contain active patient-contacting instruments; functions solely as a support structure for other dental devices. Benefits include stable patient positioning and organized integration of dental tools.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

AC-powered dental chair and operative unit. Mechanical support structure for dental handpieces and syringes. No integrated electronic sensing or software-based control systems described.

Indications for Use

Indicated for patients requiring positioning for routine dental procedures. No specific age or gender restrictions. Contraindications not specified.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "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.

Public Health Service

JUL 17 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Javier Odriozola Suarez Director J.O. Suarez & Cia. Ltda. Rua Saburo Sumiya, No 241 Aldeinha, Barueri, SP BRAZIL 06440-110

Re: K052574

Trade/Device Name: Compact Plus, Perfect Plus, Extreme Operative Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental operative unit and accessories Regulatory Class: I Product Code: EIA Dated: June 29, 2006 Received: July 3, 2006

Dear Mr. Suarez:

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.

{1}------------------------------------------------

Page 2 - Mr. Suarez

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 vour 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,

Snylie Y. Michael M.D.

Chíu 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

{2}------------------------------------------------

## Indications for Use

ს . ر (k) Number (if known): K052574

Device Name:

COMPACT PLUS, PERFECT PLUS, EXTREME OPERATIVE DENTAL UNIT

Indications For Use:

THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.

Prescription Use XDENTIST (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

(oncurrence of CDRH, Office of Device Evaluation (ODE)

nesthesiology, General Hospital, lon Control, Dental Devices

Number: K052574