(196 days)
The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.
The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.
These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.
The provided document describes the EndoPilot2, a dental device, for which the manufacturer, Schlumbohm GmbH & Co. KG, sought 510(k) clearance from the FDA. The submission (K202906) claims substantial equivalence to predicate devices: EMS-200 and SUPRASSON P5 NEWTRON. The document details the non-clinical performance data used to support this claim.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" against which specific quantitative numerical performance metrics of the EndoPilot2 are directly compared. Instead, it describes various non-clinical performance tests conducted and states that the device "PASSED required testing" or "all requirements were met."
Therefore, I will extract the performance specifications and the stated outcome for the most relevant functional components where quantitative values are mentioned, and then for other types of tests, I will summarize the general pass/fail outcome.
| Acceptance Criteria (Predicate Device Specification or Standard Requirement) | Reported Device Performance (EndoPilot2) |
|---|---|
| Apex Locator Function (Based on Predicate EMS-200) | |
| Accuracy of Apex Locating point |
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.