(28 days)
Not Found
No
The summary describes a standard dental operative unit with no mention of AI or ML components or functionalities.
No
The device is described as supplying power to and serving as a base for dental devices, and its components (chair, instrument board, light, etc.) indicate it's a general dental operative unit, not one that directly delivers therapy or treatment.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to supply power to and serve as a base for dental devices and accessories," and the "Device Description" lists components like a patient treatment chair, instrument boards, and a dental light. None of these descriptions suggest the device is used for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components (Patient Treatment Chair, Dentist's Instrument Board, etc.), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "supply power to and serve as a base for dental devices and accessories." This describes a piece of equipment used in a dental procedure, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The components listed (patient chair, instrument board, etc.) are all typical parts of a dental treatment unit used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing procedures.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This dental operative unit does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIA
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 .
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
Not Found
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)
The American Dental Technologies Dental Operative Units comply with the requirements of EN 60601-1 and 60601-1-2.
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
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: 361-289-1145
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 .
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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.
3
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 (301) 594-4692. Additionally, for questions on Compliance at (501) 332 / 332 / 324 device, please contact che promocion and adversions (301) 594-4639. 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
4
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
CONFIDENTIAL Page vi