FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. The maximum allowable speed to 400,000/min. FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ.
Item Tag: does njot apply
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100pcs Dental Diamond Burs FG 1.6mm 20 Types for High Speed Handpiece Tubine
FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. The maximum allowable speed to 400,000/min. FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ.