510(k) K093518 ยท DZE Implant, Endosseous, Root-Form
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
| Applicant | Ace Surgical Supply Co., Inc., Brockton MA, US |
| Decision | Substantially Equivalent, Jan 14, 2010 |
| Received | Nov 13, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093518
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2017 | Ace Surgical Supply Co., Inc. INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473
Product Usage:
Non implantable dental abutment. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.