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(It is mainly for your piece of mind and comfort.). 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.

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