MODEL GDCH-2000

K092851 · Global Dental Direct, Inc. · EIA · Sep 29, 2009 · Dental

Device Facts

• Record ID: K092851
• Device Name: MODEL GDCH-2000
• Applicant: Global Dental Direct, Inc.
• Product Code: EIA · Dental
• Decision Date: Sep 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Indications for Use

Global GDCH - 2000 is a dental operative unit attached to a dental patient chair. The dental operative unit is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device also functions to deliver air, water and vacuum to the dental devices/accessories. The device is attached to a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.

Device Story

Global GDCH-2000 is an AC-powered dental operative unit; attaches to dental patient chair; serves as base for dental devices/accessories. Supplies power, air, water, and vacuum to connected instruments. Features swiveling design for left/right-handed use; supports two-handed and four-handed treatment sequences. Operated by dentists and qualified professionals in clinical settings. Includes digital control system with graphical user interface (GUI) for ease-of-use. Facilitates patient positioning and instrument management during dental procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with UL 60601-1 and CSA-C22.2 No. 601.1-90 standards verified by accredited testing laboratory.

Technological Characteristics

AC-powered dental operative unit; swiveling arm design; digital control system with GUI. Energy source: AC power. Connectivity: Integrated delivery system for air, water, and vacuum. Standards: UL 60601-1, CSA-C22.2 No. 601.1-90.

Indications for Use

Indicated for use by dentists and qualified professionals as a dental operative unit attached to a patient chair to supply power, air, water, and vacuum to dental accessories and to position patients for dental procedures.

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

• Adec 532 Delivery System (K032756)

Submission Summary (Full Text)

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K092851

SEP 24 2003
Global Dental Direct Inc
510(k) Notification
GDCH 2000

July 18, 2009

Encl 12 Page 12-1

Image /page/0/Picture/4 description: The image shows the logo for Global Dental Direct. The logo features a stylized globe with lines representing longitude and latitude. A stylized dental chair is superimposed over the globe. Below the globe, the words "GLOBAL DENTAL DIRECT" are printed in a serif font, with "GLOBAL DENTAL" on the first line and "DIRECT" on the second line.

# 510(K) SUMMARY

## PRODUCT, CLASSIFICATION NAME

Trade name: Global GDCH - 2000 Common name: Dental unit attached to patient chair Classification: EIA. Class 1 Regulation number: 872.6640

# OWNER & MANUFACTURER

Global Dental Direct Inc. #4 - 2120 Paramount Crescent Abbotsford, B.C. Canada V2T 6A5 Phone:[phone] Fax: [phone] Contact person: Don Temple

### UNITED STATES SALES REPRESENTATIVE (U.S. DESIGNATED AGENT)

Planmeca USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone :[phone] Fax :[phone] Contact person: Bob Pienkowski

#### INTENDED USE

Global GDCH - 2000 is a dental operative unit attached to a dental patient chair. The dental operative unit is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device also functions to deliver air, water and vacuum to the dental devices/accessories. The device is attached to a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.

# PRODUCT DESCRIPTION

The Global GDCH - 2000 is a dental operative unit attached to a dental patient chair. The design is very flexible with many functions, both left-handed and right-handed use is easily obtainable. The dentist and assistant are allowed to change their working postures and positions according to the operation to be performed. The versatile swiveling function enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use.

#### SUBSTANTIAL EQUIVALENCE

We consider this new product to be similar in design, composition and function to the following device introduced into commercial distribution after Dec 4, 2003:

Adec 532 Delivery System #K032756

The device has similar technological characteristics (i.e. design, material, energy source, dimensions, weight). The comparison of characteristics supports substantial equivalence. Comparable non-clinical tests have been conducted (such as Encl. 13 -- Appendix 8-1 attached from an accredited testing laboratory). Similar Standards (UL 60601-1 and CSA-C22.2 No. 601.1-90 were used in testing of the devices. The end use and user of the Global GDCH 2000 and the Adec unit are substantially equivalent.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

SEP 2 9 7009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Global Dental Direct, Incorporated C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K092851

Trade/Device Name: Global GDCH-2000 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 15, 2009 Received: September 16, 2009

Dear Mr. Kogoma:

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 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. Kogoma

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Th fair

Susan Runner, D.D.S., M.A. Acting 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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Global Dental Direct Inc 510(k) Notification GDCH 2000

July 18, 2009

Encl 11

Page 11-1

GLOBAL DENTA
DIRECT

# Indications for Use

510(k) Number |K092851

Device Name:

Global GDCH - 2000

## Indications For Use:

Global GDCH - 2000 is a dental operative unit attached to patient chair. The dental operative unit is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device also functions to deliver air, water and vacuum to the dental devices/accessories. The device is attached to dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly

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

510(k) Number: K092851