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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.

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