(126 days)
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Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML.
No
The device reduces water bacteria in the water number and is used in conjunction with other treatment devices. It does not directly treat a human condition or disease, which is typically a requirement for a therapeutic device.
No
The "Intended Use" states the device is to "reduce Water bacteria in the water number o," which indicates a treatment or maintenance function, not a diagnostic one.
Unknown
The provided text is incomplete and lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that provides UV-exposed water for dental treatment devices to reduce bacteria in the water. This is a water treatment function, not a diagnostic function.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not interact with human specimens for diagnostic purposes.
The device's function is to improve the quality of water used in a dental setting, which is a supportive or preparatory function for dental procedures, not a diagnostic one.
N/A
Intended Use / Indications for Use
A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o
Product codes
EIA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human figures within its body, representing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using black ink on a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 2 |997
Mr. Richard W. Hanson Official Correspondent Dental Components Incorporated 305 North Springbrook Road Newberq, Oregon 97132
Re: K971727 DCI Water Purifier Trade Name: Regulatory Class: I Product Code: EIA Dated: August 19, 1997 Received: Auqust 22, 1997
Dear Mr. Hanson:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Hanson
through 542 of the Act for devices under the Electronic enrough Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA assorizon in formalence 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Creciente/for
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
K971727 510(k) Number (if known):
Device Name: DCI WATER PURIFIER
Indications For Use:
A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruanev
n Sion-Off f Dental, Infection Cor
Prescription Use (Per 21 CFR 801.109
OR
Over - The-Counter Use -
(Optional Format 1-2-96)