510(k) K081005 ยท NHA Abutment, Implant, Dental, Endosseous
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
| Applicant | Institut Straumann AG, Andover MA, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Apr 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2012 | Straumann USA, LLC Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant
Article Number: 027.2650
Product Usage:
Dental implants are intended for surgical placement in maxillary and/o Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.