(237 days)
Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.
Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.
The provided text is a 510(k) summary for a medical device called "Papacarie Duo." This document is part of a submission to the FDA to demonstrate its substantial equivalence to previously cleared devices. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain specific acceptance criteria, study details, or performance data in the structured format requested.
The summary mentions that "Non-clinical performance tests were conducted according to ISO 29022:2013 using Papacarie DUO to demonstrate substantial equivalence to the predicate device, and cleaning of prepared tooth surfaces prior to bonding of restorations." It also states, "Biocompatibility of Papacarie Duo was demonstrated and the data provided in this submission according to ISO 10993-1:2018."
These statements indicate that studies were performed, but the document does not provide the acceptance criteria or the reported performance data from these studies. Therefore, I cannot complete the requested tables and details based on the provided input.
To answer your request, the following information would be needed from a more detailed study report, not present in this 510(k) summary:
- Specific acceptance criteria: What quantitative or qualitative targets did the device need to meet to be considered effective and safe?
- Reported device performance: The actual results from the tests (e.g., cleaning efficacy measurements, bond strength results, etc.).
- Study design details: Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, details of comparative effectiveness studies (if any), and standalone performance details for the "non-clinical performance tests conducted according to ISO 29022:2013."
- Details about biocompatibility testing according to ISO 10993-1:2018: While mentioned, the specific tests and their outcomes are not described here.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.