If you have one
These designs are not part of the current range as far as we could find. Your dentist can still assess and maintain them; bring any records.
| 510(k) | Decision | Device name (as filed) |
|---|---|---|
| K070857 | 28 Dec 2007 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM |
| K072980 | 20 Dec 2007 | NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS |
| K062936 | 19 Dec 2006 | NOBELPERFECT CONICAL CONNECTION |
| K041876 | 20 Aug 2004 | NOBELDIRECT OD IMPLANT |
| K031345 | 24 Jul 2003 | NOBEL DIRECT, MODELS 30937, 30938 |
| K030257 | 10 Feb 2003 | NOBEL PERFECT IMPLANT SYSTEM |
6 record(s) from the openFDA 510(k) database, retrieved 28 Sep 2026. A 510(k) clearance means FDA found a device substantially equivalent to one already on the market; it is not a quality ranking.
Last updated 28 Sep 2026 · How we review
Sources
- Regulatory recordopenFDA 510(k) database — records with applicant "Nobel Biocare" (endosseous implants DZE and abutments NHA) — U.S. Food and Drug Administration (openFDA), 2026-09-28. Accessed 28 Sep 2026.
Educational information only. The choice of implant system depends on your anatomy, restorative plan, bone quality and the clinician's assessment. This website does not recommend a specific implant for you.