510(k) K150938 · DZE Implant, Endosseous, Root-Form
Straumann® Dental Implant System ¿ Roxolid® SLA Implants
| Applicant | Straumann USA, LLC, Andover MA, US |
| Decision | Substantially Equivalent, Jul 24, 2015 |
| Received | Apr 7, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2016 | Straumann Manufacturing, Inc. Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP
Article Number: 021.4510 Terminated |
DZE | None listed |
| Jul 14, 2016 | Straumann Manufacturing, Inc. Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP
Article Number: 021.4512 Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.