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.
USA NSK Style 20:1/1:5 Increasing Dental Motor LED Contra Angle Low Speed Handpiece. 1:5 Without Fiber Optic Handpiece. 1:5 Fiber Optic LED Handpiece. Smallest head fiber optic handpiece. High brightnessfiber optic lighting.
Standard head fiber optic handpiece. FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. High brightnessfiber optic lighting.