510(k) K083739 ยท ELW Material, Impression
HYDRORISE AND HYDROSYSTEM
| Applicant | Zhermack S.P.A., Bend OR, US |
| Decision | Substantially Equivalent, Mar 26, 2009 |
| Received | Dec 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2016 | Ivoclar Vivadent, Inc. Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY --
product Usage:
Dental impression material Terminated |
ELW | None listed |
| Nov 9, 2016 | Ivoclar Vivadent, Inc. Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY --
Product Usage:
Dental impression material Terminated |
ELW | None listed |
| Nov 9, 2016 | Ivoclar Vivadent, Inc. Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY --
Product Usage:
Dental impression material Terminated |
ELW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.