Bien Air Style 15 Electric Attachments Dental Handpiece

510(K) Number: K192233 Regulation Number: 21 CFR 872.6070 Product Code: EBZ. Small head slim body Low noise & vibration Anti-overheating system Durable 1:5 speed increasing Clean head system High brightness.

Lighting Better cooling effect High hardness Wearable Corrosion resistance. Smallest head fiber optic handpiece. The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies. 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.