(32 days)
The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.
Odyssey ITM Dental Water unit
I am sorry, but based on the provided document, I cannot answer your request. The document describes a 510(k) premarket notification for a dental water unit and focuses on regulatory approval rather than a study about the device's performance or acceptance criteria.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, or details of a test set.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details about a standalone algorithm performance study.
- The type of ground truth used.
- The sample size for a training set.
- How ground truth for a training set was established.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 DEC
Ms. Leslie Drake President Germiphene® corporation 1379 Colborne Street East Brantford, Ontario N3T5V7 CANADA
Re : K983847 Modification Of: Odyssey I™ Dental Water Trade Name: Unit Requlatory Class: I EIA Product Code: October 30, 1998 Dated: Received: October 30, 1998
Dear Ms. Drake:
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. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Ms. Drake
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 markets 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/dsmamajin.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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ODYSSEY IT'1 DENTAL WATER UNIT
510(k) Number: K983847
Indications For Use
- · The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.
Susan Runne
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices વ્યું હતું રે ચ 510(k) Number
§ 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.