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| Country Of Origin | China |
| FDA For Curing Light | 510(K) Number: K192233 |
| FDA For Handpiece | 510(K) Number: K181691 |
| FDA For Scaler | 510(K) Number: K163414 |
| Unit Type | Unit |
| Model | ES-20 |
| Brand | SANDENT |
Regulation Number: 21 CFR 872.6070. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. FDA for Curing Light 510(K) Number: K192233.