510(k) K033074 ยท NPK Barrier, Synthetic, Intraoral
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
| Applicant | Inion , Ltd., Tampere, FI |
| Decision | Substantially Equivalent, Mar 31, 2004 |
| Received | Sep 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2017 | Inion Ltd. Inion GRT Tack, drill bit and tack appl., 4x, Sterile.
Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue Terminated |
NPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.