510(k) K200858 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Mini Sterilizable Tray
| Applicant | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks CA, US |
| Decision | Substantially Equivalent, Aug 6, 2020 |
| Received | Apr 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2025 | Implant Direct Sybron Manufacturing LLC The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit i Open, Classified |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.