# K050406: Nobelspeedy Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jun 8, 2005 after 111 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894595 (1990). 18 ancestors in all.
234 later devices descend from it; 16 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041661: Nobel Biocare Endosseous Implants, Nobel Biocare Uas, Inc. (2004) Summary page 1.

## Most influential descendants
- K101207: Neodent Implant System (2010), 181 descendants of its own
- K101945: Neodent Implant System (2011), 180 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw (2014), 115 descendants of its own

## Indications for use
NOBELSPEEDY™ Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELSPEEDY Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDY Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. NOBELSPEEDY™ Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY™ Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY™ Implants are preferred in these soft bone indications because bone formation on the TiUnite® surface is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates. NOBELSPEEDY™ Implants may be tilted up to 45°. When used with angulations between 30° and 45° a minimum of four implants must be used and splinted.

Source page: https://510kreport.com/device/K050406
Methodology: https://510kreport.com/methodology