510(k) K972278 ยท LYC Bone Grafting Material, Synthetic
CYTOPLAST REGENTEX TITANIUM 250
| Applicant | Osteogenics Co., Fort Worth TX, US |
| Decision | Substantially Equivalent, Aug 6, 1997 |
| Received | Jun 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2016 | Osteogenics Biomedical, Inc. Cytoplast Titanium-Reinforced Posterior Singles Membrane
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects. Terminated |
LYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.