510(k) K221761 ยท NVK Laser, Dental, Soft Tissue
Solea
| Applicant | Convergent Dental, Inc., Needham MA, US |
| Decision | Substantially Equivalent, Sep 14, 2022 |
| Received | Jun 17, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Convergent Dental Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked Open, Classified |
NVK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.