(174 days)
Not Found
Not Found
No
The summary describes a traditional toothbrush with a liquid spray system, referencing existing manual toothbrushes and water flossers as predicate/reference devices. There is no mention of AI, ML, image processing, or any data-driven features.
No.
The device is described as a toothbrush and a liquid spray system for general oral hygiene, flushing out loose plaque and debris, which are non-therapeutic functions.
No
The device is described as a toothbrush with a liquid spray system designed to flush out loose plaque and debris, similar to a Water Pik. Its intended use is for oral hygiene, not for diagnosing a condition.
No
The device description and intended use clearly describe a physical toothbrush with a liquid spray system, indicating it is a hardware 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 describes the device as a toothbrush with a liquid spray system for flushing out plaque and debris. This is a physical action performed on the body (cleaning teeth and gums), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: While the description is not found, the intended use clearly points to a device for oral hygiene.
- Lack of Diagnostic Claims: There are no claims related to diagnosing, monitoring, or screening for any disease or condition. The claims are about cleaning and removing plaque.
- Reference Devices: The reference devices listed (toothbrushes and water flossers) are also not IVDs.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES). OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE: - 1) USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ) - 2) OVER THE COUNTER DENTIFRICE. - 3) THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE. - 4) THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLOU™ MODELS). - 5) THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.
Product codes
EFW
Device Description
Not Found
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
Not Found
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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 circular seal 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, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1998
Mr. Seymour Troy 'Ethicare™ Products P.O. Box 5027 Fort Lauderdale, Florida 33310
Re : K980995 Trade Name: PLAQ-ATAQ™-1 Regulatory Class: II Product Code: EFW Dated: May 20, 1998 Received: May 26, 1998
Dear Mr. Troy:
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 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). 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉੱ 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 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. Troy
through 542 of the Act for devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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"(21CFR 807.97). "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/dsma/dsmamain.html".
Sincerely yours,
Olin S. L/r
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
Page 2 ol 5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
PLAQ-ATAQ-I Device Name:
SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE Indications For Use: WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES).
OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE:
-
- USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., )
-
- OVER THE COUNTER DENTIFRICE.
-
- THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE.
-
- THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLOU™ MODELS).
-
- THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Co icurrence of CDRH, Office of Device Evaluation (ODE)
Suser Rraser
(Division Sign-Off)
Division of Dontal, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use V (Per 21 CFR 801.1 )9) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Image /page/2/Picture/21 description: The image shows a diagram of a molecule. The molecule appears to be composed of two larger, circular atoms on either end, connected by a chain of smaller, more complex structures. The central chain is densely packed and has a somewhat irregular, organic appearance.