(49 days)
Automatic mixing, dosing and dispensing system for ESPE's PENTA impression and bite registration materials:
- IMPREGUM® PENTA .
- Permadyne® Penta H .
- Permadyne® Penta L .
- Ramitec® Penta .
- DIMENSION® PENTA H .
- DIMENSION® PENTA H QUICK .
- DIMENSION® PENTA L .
- POSITION® PENTA .
- Position® Penta Quick .
ESPE's new mixing device for impression materials, PENTAMIX® 2, is comparable and substantially equivalent to an AC-powered dental amalgamator. It is therefore a class I device which has been exempted from premarket notification requirements (21 C.F.R. § 872.3100). However, consistent with 21 C.F.R. § 872.9, ESPE is submitting this premarket notification because the intended use of РЕ№ТАМІХ® 2 is significant different to that of САРМХ® (21 С.F.R. § 872.9 a). Furthermore, ESPE wants to give evidence that safety and effectiveness are only warranted when PENTAMIX® 2 is used together with ESPE's especially designed PENTA impression materials.
PENTAMIX® 2, as successor to PENTAMIX®, offers the same simple and convenient handling at 1.5 times the speed. The accustomed high mixing quality of impression materials remains unchanged. The higher dispensing speed achieved is, however, a significant safety factor in terms of working time for all indications, and equally represents a clear time saving. The PENTAMIX® 2 system permits more relaxed and cost-effective work, and is intended as another step towards greater precision.
This document is a 510(k) summary for the PENTAMIX® 2 automatic mixing device for dental impression materials. It's a regulatory submission to the FDA, not a study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way you might expect for a clinical or performance validation study.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (PENTAMIX® and CAPMIX®) to allow the PENTAMIX® 2 to be marketed. The key arguments for substantial equivalence are:
- Intended Use: The device is for automatically mixing and dispensing ESPE PENTA impression materials. This is largely similar to its predecessor, PENTAMIX®.
- Technological Characteristics: PENTAMIX® 2 offers the "same simple and convenient handling" but at "1.5 times the speed." The "high mixing quality... remains unchanged."
- Safety and Effectiveness: The document asserts that safety and effectiveness are warranted when PENTAMIX® 2 is used with genuine ESPE PENTA impression materials. The higher dispensing speed is presented as a "significant safety factor" by providing more working time.
Therefore, I cannot provide the requested information as it is not present in the provided text. The document does not describe a formal study with acceptance criteria, sample sizes, ground truth, or expert adjudication as would be found in a performance validation study for a diagnostic device, for example.
The information provided is typical for a 510(k) for a Class I device where the focus is on a comparison to a legally marketed predicate to demonstrate similar safety and effectiveness, rather than a de novo clinical trial.
§ 872.3100 Dental amalgamator.
(a)
Identification. A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.