(12 days)
The DentaPure® DP90 and DP365 Cartridge is for use on dental unit water lines attached to the Second handpiece, three-way air/water syringe and dynamic demail mstruments, f.e., mgr. opod has with currently recommended practices regarding ultrasonic Scaler. This outhego in setyantator stermization and Instilling of contax morent ADA recommendations for water quality having a maximum of 200 cfu/ml.
The DentaPure® DP90 and DP365 Cartridges are in-line assemblies incorporating iodinated resin and a polypropylene filter. The cartridge is connected to the municipal water supply at the air/water service junction box in each operatory. It consists of a polypropylene in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units.
The provided text describes a medical device, the DentaPure® DP90 and DP365 Cartridge, and its regulatory clearance via a 510(k) submission. However, it does not contain information related to a study proving the device meets specific acceptance criteria. The letter from the FDA confirms substantial equivalence to a predicate device and approval for marketing, but it does not detail performance testing or acceptance criteria.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study details (effect size)
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on the regulatory aspects (510(k) summary, FDA clearance letter) and general claims about the device's function and adherence to ADA guidelines (reducing bacteria levels to less than 100 cfu/ml, which is below the ADA recommendation of 200 cfu/ml). It mentions a prior equivalent device (DentaPure® DP1, K963548), suggesting that the substantial equivalence was likely based on comparison to the performance of that device, but no specific study details are given in this 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.