510(k) K053014 ยท ELW Material, Impression
POLY SILOXANE IMPRESSION MATERIAL
| Applicant | Clinician'S Choice Dental Products, Inc., London, Ontario, CA |
| Decision | Substantially Equivalent, Nov 15, 2005 |
| Received | Oct 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053014
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2022 | Clinician's Choice Dental Products Inc. Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure.
Product ID: 013912 Terminated |
ELW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.