AGATHA-A-H2010

K983374 · Midian Intl. · EFS · Dec 23, 1998 · Dental

Device Facts

• Record ID: K983374
• Device Name: AGATHA-A-H2010
• Applicant: Midian Intl.
• Product Code: EFS · Dental
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6510
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.

Device Story

Agatha-A-H2010 is an oral hygiene device designed for patients physically unable to perform manual brushing. It functions to remove adherent plaque and debris from teeth and oral mucosa. By providing an alternative to mechanical brushing, the device aims to reduce tooth decay and prevent aspiration in this specific patient population. It is intended for use in clinical or care settings where patients require assistance with oral hygiene.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification review.

Technological Characteristics

Oral hygiene device for plaque and debris removal. No specific materials, energy sources, or software algorithms described in the provided documentation.

Indications for Use

Indicated for patients physically unable to perform brushing to remove adherent plaque and debris from teeth and oral mucosa, reduce tooth decay, and prevent aspiration associated with mechanical brushing.

Regulatory Classification

Identification

An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1998

Mr. Chris Montalbano Midian International 5821 NW 28th Street Lauderhill, Florida 33313

K983374 Re : Agatha-A-H2010 Trade Name: Requlatory Class: I Product Code: EFS Dated: September 18, 1998 September 25, 1998 Received:

Dear Mr. Montalbano:

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 reqistration, 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. ਉ 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. 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

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Page 2 - Mr. Montalbano

through 542 of the Act for devices under the Electronic chrough Sta Or on 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 deberized in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets processor with 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 regarddiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page **_ of _**

510(k) Number (if known):

Device Name: Agatha -A-H2010

Indications For Use: To Remove adherent plaque and
FOOD, debris from the teeth and oral mucosa,
to Educ.e tooth decay in patients who are
Reduce
Physically unable to perform brushing.
To Prevent Aspiration, which may be associated
with michanical brushing only in these patients.

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Concurrence of CDRH, Office of Device Evaluation of

(Division Sign-Off) Ponnali C. Division of Dental, Infection Contro and General Hospital Devices

1983374 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)