GULLIVER AND CLASSE A

K012213 · American Dental Technologies, Inc. · EIA · Aug 13, 2001 · Dental

Device Facts

• Record ID: K012213
• Device Name: GULLIVER AND CLASSE A
• Applicant: American Dental Technologies, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The Gulliver and Classe A Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.

Device Story

Dental operative units (Gulliver and Classe A models) serve as base platforms for dental procedures. Components include patient treatment chair, dentist's instrument board, assistant's board, cuspidor/water system, and overhead dental light. Units are electrically or pneumatically operated. Operated by dental professionals in clinical settings to support various dental instruments and accessories. Provides stable positioning and power for clinical dental workflows.

Clinical Evidence

Bench testing only. Compliance with EN 60601-1 and 60601-1-2 standards demonstrated.

Technological Characteristics

Dental operative unit; electrical or pneumatic power source. Includes patient chair, instrument boards, cuspidor, and overhead light. Complies with EN 60601-1 (general safety) and EN 60601-1-2 (electromagnetic compatibility) standards.

Indications for Use

Indicated for use as a base and power supply for dental devices and accessories in a clinical dental 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.

Predicate Devices

• Sirona Dental Systems Sirona C8 (K983242)

Submission Summary (Full Text)

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K012213

# 510(k) Summary for American Dental Technologies Dental Operative Units

#### 1. SPONSOR

American Dental Technologies 5555 Bear Lane Corpus Christi, Texas 78405

Contact Person: John Vickers Telephone: [phone]

Date Prepared: July 3, 2001

#### 2. DEVICE NAME

Proprietary Name: Gulliver and Classe A Dental Operative Unit Common/Usual Name: Dental Operative Unit Classification Name: Dental Operative Unit with Accessories

#### 3. PREDICATE DEVICES

Sirona Dental Systems Sirona C8 (K983242).

#### 4. DEVICE DESCRIPTION

The American Dental Technologies Dental Operative Units are standard electrical or pneumatically operated dental operative units that will be available in two product lines, the Gulliver and the Classe A, and several models. Both the Gulliver and Classe A Dental Operative Units consist of the following major components:

- Patient Treatment Chair .
- The Dentist's Instrument Board .
- Assistants Board .
- Cuspidor/Water system .
- Overhead Dental Light .

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#### 5. INTENDED USE

The Gulliver and Classe A Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The American Dental Technologies Gulliver and Classe A Dental Operative Units and Accessories are substantially equivalent to the Sirona Dental Systems C8. The American Dental Technologies Gulliver and Classe A Dental Operative Units and the Sirona C8 have the same intended use.

The proposed and predicate devices use similar components, and are similar in design, characteristics, and mode of operation. Both systems include a chair, dentist's instrument board, cuspidor, assistant's board, dental light, and footswitches for control of the various functions.

#### PERFORMANCE TESTING 7.

The American Dental Technologies Dental Operative Units comply with the requirements of EN 60601-1 and 60601-1-2.

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AUG 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald J. Sherratt Medical Stream Director American Dental Technologies, Incorporated C/O Intertek Testing Services 70 Codman Hill Road 01779 Boxborough, Massachusetts

Re: K012213 Trade/Device Name: Gulliver and Classe A 872.6640 Requlation Number: Requlatory Class: I Product Code: EIA Dated: August 3, 2001 Received: August 7, 2001

Dear Mr. Sherratt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate abe beach in closes ate 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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## Page 2 - Mr. Sherratt

concerning your device in the Eederal Register. Please note: concerning your device remarket notification submission does this response to your promobile have under sections 531 not arrect any obligation for devices under the Electronic through 542 of the Act for acvisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as mis receer will and of the premarket notification. The FDA described in your sistin promise of your device to a legally marketed predicate device results in a classification for your marketed predicate acvice results to proceed to the market.

If you desire specific advice for your device on our labeling II you desire bpoories and additionally 809.10 for in regulation (ar erk rires), please contact the Office of Compliance at [phone]. Additionally, for questions on Compliance at (501) 332 / 332 / 324 device, please contact che promocion and adversions [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). J Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibion on binance at its toll-free number Incernational and combames - 6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Cim S f/on

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 012213

Device Name: American Technologies Gulliver and Classe A Dental Operative Units

Indications For Use:

The American Dental Technologies Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runno

(Division Sign-Off) Division of Ophthalmic De 510(k) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over-The-Counter Use __

(Optional Format 1-2-96)

American Dental Technologies 510(k) Gulliver and Classe A Dental Operative Units July 3, 2001

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