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Product Code: EBZ. Product Code: ELC. Regulation Number: 872.4850. 510(K) Number: K163414. FDA for Scaler Subsequent Product Code: EGS. Classification Product Code: EFB. Regulation Number: 872.4200.

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