FDA records
| 510(k) | Decision | Device name (as filed) |
|---|---|---|
| K073142 | 11 Jan 2008 | NOBELREPLACE HEXAGONAL IMPLANT |
| K062566 | 6 Dec 2006 | NOBELREPLACE TAPERED CONICAL CONNECTION |
| K023952 | 16 Jan 2003 | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE |
| K022424 | 27 Sep 2002 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 |
| K023113 | 26 Sep 2002 | REPLACE TIUNITE ENDOSSEOUS IMPLANT |
| K021584 | 5 Jun 2002 | REPLACE SCALLOPED MARGIN IMPLANT SYSTEM |
| K020646 | 29 May 2002 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 |
| K002475 | 9 Nov 2000 | REPLACE TPS COATED IMPLANTS |
8 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.
Clinical review pending. Facts on this page are checked against the sources listed below (regulatory records, manufacturer documents, peer-reviewed research). A named clinician will review it before we call it medically reviewed.
Last updated 28 Sep 2026 · How we review
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.
