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| Model | Replace cartridge |
| FDA For Curing Light | 510(K) Number: K192233 |
| FDA For Handpiece | 510(K) Number: K181691 |
| FDA For Scaler | 510(K) Number: K163414 |
| Handpiece Type | High Speed |
| Brand | Unbranded |
FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ.