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FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ. FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS.

A maxillary second molar and a mandibular second premolar were shaped with files, and smooth uniformly tapered canals were created more easily than with stainless steel hand files. During use of NiTi rotary files, it is necessary to consider their potential for breakage.

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