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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.