510(k) K142371 ยท EBG Crown And Bridge, Temporary, Resin
Luminesse PMMA
| Applicant | Talladium, Inc., Valencia CA, US |
| Decision | Substantially Equivalent, Apr 24, 2015 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2020 | Talladium Inc Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on Terminated |
EBG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.