If you have one
Keep your implant passport. External-hex parts differ from conical connection parts; your dentist needs the exact product to order components.
| 510(k) | Decision | Device name (as filed) |
|---|---|---|
| K160119 | 2 Jun 2016 | NobelSpeedy Groovy |
| K050406 | 8 Jun 2005 | NOBELSPEEDY IMPLANTS |
2 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.
- Regulatory recordFDA 510(k) K160119 — NobelSpeedy Groovy — U.S. Food and Drug Administration, 2016-06-02. 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.
