(86 days)
This product has been specially formulated and clinically proven to clean deposits and control bacterial contamination in Dental Unit Water Lines.
Ultra-Kleen Powder for Dental Unit Water Lines, Models 513
The provided text is a notification from the FDA regarding the clearance of a device, "Ultra-Kleen Powder for Dental Unit Water Lines," but it does not contain the detailed information required to answer the specific questions about acceptance criteria and the study that proves the device meets those criteria. The letter is a regulatory document confirming substantial equivalence to a predicate device, not a summary of a performance study.
Therefore, I cannot provide the requested information from the given text. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about test sets.
- Information on the number or qualifications of experts, or adjudication methods.
- Details about multi-reader multi-case studies or effect sizes.
- Information about standalone algorithm performance.
- The type of ground truth used.
- Sample sizes for training sets.
- How ground truth for training sets was established.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 1999
Shira Kramer, Ph.D. President The Sterilex® Corporation 7-I Gwynns Mill Court Owings Mills, Maryland 21117
Re: K991946 Ultra-Kleen Powder for Dental Unit Water Trade Name: Lines, Models 513 Requlatory Class: I Product Code: EIA Dated: June 2, 1999 Received: June 9, 1999
Dear Dr. Kramer:
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. ਮ 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 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 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 - Dr. Kramer
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 ating 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 requlation (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 qeneral 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,
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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510(k) Number (if known):
:
Ultra-Kleen Liquid for Dental Unit Water Lines Device Name:
Indications For Use:
This product has been specially formulated and clinically proven to clean deposits and control bacterial contamination in Dental Unit Water Lines.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swer Runer
(Division Sign-Off)
(Division of Dental, Infection Control, and General Hospital Device 510(k) Number . Ga
Prescription Use
X
(Per 21 CFR 80I.109)
ﻧﺴ
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
. 9800 XB.I. CONSTIL
§ 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.