510(k) K012511 ยท MXF System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
WATERLASE MILLENNIUM
| Applicant | Biolase Technology, Inc., Clemente CA, US |
| Decision | Substantially Equivalent, Jan 18, 2002 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012511
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.