(13 days)
Not Found
No
The description focuses on the mechanical and digital control aspects of a dental operative unit, with no mention of AI or ML capabilities.
No.
The device is a dental operative unit, which supplies power to and serves as a base for other dental devices and accessories, and delivers air, water, and vacuum. It does not directly provide therapy.
No
The device description indicates it is a dental operative unit that supplies power, air, water, and vacuum to other dental devices and accessories, and positions the patient. It does not mention any function for diagnosing conditions.
No
The device is described as a physical dental operative unit with hardware components (AC power, air, water, vacuum delivery, digital control system with GUI) attached to a patient chair, not solely software.
Based on the provided information, the Global GDCH - 2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a dental operative unit attached to a patient chair. Its function is to supply power, air, water, and vacuum to other dental devices and accessories, and to position the patient. This is a device used in vivo (on a living patient) for dental procedures, not in vitro (outside the body) for diagnostic testing of samples.
- Device Description: The description reinforces its role as a dental operative unit and patient chair, focusing on its physical design and features for dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the Global GDCH - 2000 falls under the category of a dental device used for treatment and procedures, not an IVD device used for diagnosis.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other legally qualified professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
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.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
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:604-557-1150 Fax: 604-859-1165 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 :(630) 529 2300 Fax :(630) 529 1929 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.
1
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.
2
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 (800) 638-2041 or (301) 796-7100 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
3
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