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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
FDA for Scaler: 510(K) Number: K163414 Regulation Number: 872.4850 Product Code: ELC
FDA for Handpiece: 510(K) Number: K181691 Regulation Number: 872.4200 Classification Product Code: EFB Subsequent Product Code: EGS