LOGOS JUNIOR DENTAL CHAIR AND UNIT

K023513 · Castellini S.P.A. · EIA · Mar 26, 2003 · Dental

Device Facts

• Record ID: K023513
• Device Name: LOGOS JUNIOR DENTAL CHAIR AND UNIT
• Applicant: Castellini S.P.A.
• Product Code: EIA · Dental
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Logos Junior dental unit and accessories are indicated for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists.

Device Story

Logos Junior Dental Chair and Unit is a dental operatory system used by dental professionals (dentists, hygienists, assistants) to facilitate patient positioning and dental procedures. The device consists of a chair and integrated dental unit accessories. It functions as a support platform for patient treatment in a clinical dental environment. It does not involve automated data processing or software-driven clinical decision support.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental operative unit and chair. Class I device (21 CFR 872.6640). Mechanical/electromechanical assembly for patient positioning and dental instrument support.

Indications for Use

Indicated for use by dentists, dental assistants, and dental hygienists for the provision of dental treatment in a dental operatory setting.

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)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or faces, stacked on top of each other, with flowing lines beneath them.

Public Health Service

9200 C
Rockvi

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Giuliano Lanzarini Responsible for Product Safety Castellini S.p.A. Via Saliceto, 22 40013 Castel Maggiore Bologna, ITALY

Re: K023513

Trade/Device Name: Logos Junior Dental Chair and Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: January 16, 2003 Received: January 21, 2003

Dear Mr. Lanzarini:

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.

MAR 2 6 2003

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 vour 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. Lanzarini

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 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/dsma/dsmamain.html

Sincerely yours,

Susan Ruane HPLfor

Susan Runner, DDS, MA Interim 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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510(k) Number (if known): K023513

Device Name:LOGOS JUNIOR DENTAL CHAIR AND UNIT

Indications For Use: The Logos Junior dental unit and accessories are indicated for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists.

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

Suzen Ranna

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Ancolnection of Antal Devices

510(k) Number: I902357

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