510(k) K033922 ยท DZE Implant, Endosseous, Root-Form
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
| Applicant | Institut Straumann AG, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 7, 2004 |
| Received | Dec 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033922
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2012 | Straumann USA, LLC Straumann Standard Plus Implant 04.8mm Wide Neck
SLA 10mm
Article Number: 043.652S.
Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for p Terminated |
NDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.