(191 days)
FOR USE TO REDUCE BACTERIA AND VIRUSES PRESENT IN DENTAL UNIT WATER LINE WATER. THE DEVICE CAN BE USED ON THE GENERAL PATIENT POPULATION, WITH THE EXCEPTION OF PATIENTS WHO ARE PREGNANT OF WHO ARE SENSITIVE TO IODINE.
DENTAL UNIT WATER TREATMENT CARTRIDGE
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA to Dentalpure Corporation for a "Dental Unit Water Treatment Cartridge."
It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device. The document also includes the indications for use of the device.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen J. Poindexter ·President Dentalpure Corporation 300 South Owasson Boulevard St. Paul, Minnesota 55117
JUN 19 1997
K964942 Re : Dental Unit Water Treatment Cartridge Trade Name: Requlatory Class: I Product Code: EIA Dated: May 16, 1997 May 20, 1997 Received:
Dear Mr. Poindexter:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. पु substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Poindexter
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets production 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 ritro 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 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 at (301) 443-6597.
Sincerely yours,
Sloontumoe
n Timothy A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page / of /
-510(k) Number (if known): K964942
Device Name: DENTAL UNIT WATER TREATMENT
OARTRIDGE
Indications For Use: REDUCE 6-16-99
FOR USE TO BACTERIA AND
VIRUSES PRESENT IN DENTAL
UNIT WATER LINE WATER. THE
DEVICE CAN BE USED ON THE
GENERAL PATIENT POPULATION,
WITH THE EXCEPTION OF PATIENTS
WHO ARE PREGNANT OF WHO ARE
SENSITIVE TO FODINE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
USE ON ANOTHER PAGE IF NEEDED
acurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off n of Dental, Infection Co neral Host
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.