CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT

K081237 · Craftmaster Contour Equipment, Inc. · EIA · Aug 25, 2008 · Dental

Device Facts

• Record ID: K081237
• Device Name: CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
• Applicant: Craftmaster Contour Equipment, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The CCEI Vista, Satellite Mobile Unit and Satellite Unit are dental operative units that are intended to supply utilities to and serve as a base for dental tools and accessories.

Device Story

The Vista, Satellite Mobile Unit, and Satellite Unit are dental operative units designed to provide necessary utilities (e.g., air, water, power) and serve as a mounting base for various dental instruments and accessories. These units are used in dental clinics by dental professionals to facilitate patient treatment. The device functions as a support system for dental tools, allowing the practitioner to organize and access equipment during procedures. It does not perform diagnostic or therapeutic functions itself but supports the operation of other dental devices.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental operative unit providing utility support (air, water, power) for dental instruments. Form factor includes mobile and stationary configurations. Class I device. No software or complex algorithms.

Indications for Use

Indicated for use as a dental operative unit to supply utilities and serve as a base for dental tools 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.

Submission Summary (Full Text)

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K081237

## SECTION 5 – 510(k) SUMMARY

| Submission Correspondent: | Emergo Group, Inc. | AUG 25 2008 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | 1705 S. Capital of Texas Hwy<br>Suite 500<br>Austin, TX 78746 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Contact: | Stuart R. Goldman | |
| Submission Sponsor: | Craftmaster Contour Equipment, Inc.<br>PO Box 331345<br>Ft. Worth. TX 76163-1345<br>800.475.9260<br>817.568.9260<br>www.ccei.net | |
| Date Prepared: | April 9, 2008 | |
| Trade Name(s): | 1. Vista<br>2. Satellite Mobile Unit<br>3. Satellite Unit | |
| Common/Usual Name(s): | Unit, Operative Dental (primary)<br>Chair, Dental, With Operative Unit (secondary) | |
| Classification Name(s): | Dental Operative Unit and Accessories (primary)<br>Dental Chair and Accessories (secondary) | |
| Classification Number(s): | 872.6640 (primary)<br>872.6250 (secondary) | |
| Classification Panel: | Dental Devices | |
| CDRH Product Code: | EIA (primary)<br>KLC (secondary) | |
| Regulatory Class: | I | |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Craftmaster Contour Equipment, Incorporated C/o Mr. Stuart R. Goldmen Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway Suite 500 Austin, Texas 78746

AUG 2 5 2008

Rc: K081237

Trade/Device Name: Vista Satellite Mobile Unit Satellite Unit

Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: July 14, 2008 Received: July 15, 2008

Dear Mr. Goldmen:

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. Goldmen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Chiu S. Lin, Ph.D.

Chiu S. Lin. Ph. D Division 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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## INDICATION'S FOR USE

510(k) Number (if known): K081237

## Device Name:

- l . Vista
2. Satellite Mobile Unit

3. Satellite Unit

## Indications for Use:

The CCEI Vista, Satellite Mobile Unit and Satellite Unit are dental operative units that are intended to supply utilities to and serve as a base for dental tools and accessories.

Prescription Use __ X (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 IF NEEDED)

Suza Runser

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

510(k) Number: 1081237

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