(398 days)
For use in pressurized self-contained water devices.
For use in cleaning lines in dental units by leaving the solution (Bio2000), dispensed by a pressurized device, overnight (similar period of time) or use continuously. Cleaning lines refers to the reduction of microbial contamination.
For use in operative procedures to dedicated coolant (water) line for air or electric driven handpieces and scalers. Use of this device and solution will increase cutting efficiency and decrease the bad odors and tastes that occur during operative procedures while decreasing microbial contamination of the lubing.
Not Found
I am sorry, but the provided documents do not contain information typically found in a study describing acceptance criteria and device performance. The documents are a regulatory letter from the FDA regarding a 510(k) submission for a device called "Bio-2000" and the device's indications for use.
To fulfill your request, I would need a different type of document, such as:
- A clinical study report
- A performance evaluation report
- A regulatory submission document that includes detailed testing results.
The current documents only state that the device is "substantially equivalent" to legally marketed predicate devices and outline its intended uses for cleaning dental unit lines and improving operative procedures by reducing microbial contamination. They do not provide:
- A table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.).
- Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for training or testing sets.
- Sample size for a training set.
Therefore, I cannot extract the requested information from the provided text.
§ 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.