510(k) K972027 ยท ELW Material, Impression
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
| Applicant | Zhermack S.P.A., St Louis MO, US |
| Decision | Substantially Equivalent, Jul 16, 1997 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2013 | Ultradent Products, Inc. Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. Terminated |
ELW | None listed |
| Feb 13, 2013 | Ultradent Products, Inc. Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics. Terminated |
ELW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.