COCOON HYGIENIST

K040529 · Satelec · EIA · Aug 19, 2004 · Dental

Device Facts

• Record ID: K040529
• Device Name: COCOON HYGIENIST
• Applicant: Satelec
• Product Code: EIA · Dental
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Cocoon® Hygienist is a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals.

Device Story

Cocoon Hygienist is a dental operative unit serving as an interface between supply utilities (air, water, suction, electricity) and dental hand instruments. Operated by dentists, dental hygienists, or other dental professionals in a clinical setting. Provides a base for tools; includes manual controls for water flow to handpieces and syringes. Output air pressure is preset. Device facilitates dental operations by centralizing utility connections.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dental operative unit; provides interface for air, water, suction, and electricity. Includes manual controls for water flow and preset air pressure. No software or electronic processing components described.

Indications for Use

Indicated for use by dental professionals as a base and utility supply interface for dental tools and accessories.

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.

Predicate Devices

• Boyd Delivery Units (K020833)

Submission Summary (Full Text)

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K040529

Pascal Dupevron Regulatory Affairs

## 8. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

- A. Submitter Information
SATELEC Z.1. du Phare, BP 216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

Telephone: [phone]

Contact Person:

Date Prepared: February 25, 2004

- B. Device Identification

| Common/Usual Name: | Delivery System |
|--------------------|------------------|
| Proprietary Name: | Cocoon Hygienist |

## C. Identification of Predicate Devices

The Cocoon Hygienist is substantially equivalent to the predicate device by Boyd Industries, Inc., Boyd Delivery Units (K020833) previously cleared by FDA and currently marketed.

## D. Device Description

The Cocoon Hygienist is a dental operative unit that provides the dentist with primary requirements for dental operations. The delivery system is designed to be used as an interface device to connect the dental operating hand instruments to the appropriate supply utilities such as air, water suction, drain, and electricity. The unit is supplied with controls that allow the dentist. dental hygienist, or operator to set the water flow to the hand pieces. The water flow of the syringe, directly connected to main water supply, depends on the input water pressure. The output air pressure is preset in the unit.

The intended use of the Satelec Cocoon Hygienist is to supply utilities to and serve as a base for dental tools and accessories for the dental professional.

## E. Substantial Equivalence:

The technical characteristics of the Cocoon Hygienist are almost identical to those of the Boyd Industries Inc., Dental Operative Units (K020833). Differences that exist between the systems relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the Cocoon Hygienist.

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Image /page/1/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 that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

Satelec C/O Dr. Jean-Luc Boulnois President Interactive Consulting, Incorporated 70 Walnut Street Wellesley, Massachusetts 02481

Re: K040529

Trade/Device Name: Cocoon® Hygienist Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 10, 2004 Received: August 11, 2004

Dear Dr. Boulnois:

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 - Ms. Boswell

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 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 yours,

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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510(k) Number (if known):

Ko40529

Device Name: Cocoon® Hygienist

Indications for Use:

The Cocoon® Hygienist is a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals.

Please refer to the attached listing for a complete description.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Romano

n of Anesthesiology, General Hospital. Infection Control Dental D

510(k) Number: J(040526

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use