FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ.
SKYSEA 1020AM-M4 low speed Internal Water Spray Low Speed Handpiece (Complete set). Straight handpiece Model: SKYSEA 1020SH(internal spray nozzle, be applicable to SKYSEA E-TYPE motor). Ratio: E-type Low Speed Handpiece 1:1 Ratio, with Internal water Cooling System.
FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. 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 Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ.