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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.
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FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies.
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