510(k) K012174 ยท EIH Powder, Porcelain
ERIS LAYERING MATERIALS
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Aug 27, 2001 |
| Received | Jul 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2015 | Ivoclar Vivadent, Inc. IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations Terminated |
EIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.