510(k) K933505 ยท LBH Varnish, Cavity
BOSWORTH COPALIONER
| Applicant | Harry J. Bosworth Co., Skokie IL, US |
| Decision | Substantially Equivalent, Jan 7, 1994 |
| Received | Jul 15, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2023 | Keystone Industries Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina
Item Open, Classified |
LBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.