21 CFR 872.6070

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.

Single use prophy angles: Compatible with all universal disposable prophy angles, and refuse to reuse to ensure clean and safe. Hygiene Prophy Handpiece. Disposable prophy angles 2pcs. FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS.