510(k) K030685 ยท DZE Implant, Endosseous, Root-Form
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
| Applicant | Nobel Biocare AB, Yorba Linda, CA, US |
| Decision | Substantially Equivalent, Feb 6, 2004 |
| Received | Mar 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2020 | Nobel Biocare Usa Llc Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.