Company name: Dreamland Technology Ltd. City, State: Beijing, China. Important Notice For U. Food & Drug Administration and state and local regulatory agencies. If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA’s Center for Devices and Radiological Health. This dental items is not meant to replace your doctor diagnostic. It is mainly for your piece of mind and comfort. FDA for Curing Light. 510(K) Number: K192233. Regulation Number: 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 Scaler : 510(K) Number: K163414, Regulation Number: 872.4850, Product Code: ELC.
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