(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.
§ 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.