510(k) K913980 ยท EBZ Activator, Ultraviolet, For Polymerization
HELIOLUX
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Dec 16, 1991 |
| Received | Sep 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913980
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.