510(k) K100232 ยท EIH Powder, Porcelain
LUMINESSE ZR BLANKS
| Applicant | Talladium, Inc., Valencia CA, US |
| Decision | Substantially Equivalent, May 21, 2010 |
| Received | Jan 26, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2020 | Talladium Inc Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-cer Terminated |
EIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.