# K160119: NobelSpeedy Groovy

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jun 2, 2016 after 135 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: 9 generations back to K925765 (1993). 71 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 4.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 4.

## Most influential descendants
- K190958: Neodent Implant System (2019), 5 descendants of its own
- K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments (2022), 3 descendants of its own
- K252168: Straumann® BLC Implants - Indication Widening (2026), 0 descendants of its own
- K252090: Pterygoid Indication for GM Helix Implants (2025), 0 descendants of its own
- K251148: JDEvolution Plus L and JDEvolution Plus LE (2025), 0 descendants of its own

## Indications for use
NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bi-cortical anchorage in cases of reduced bone density. NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

Source page: https://510kreport.com/device/K160119
Methodology: https://510kreport.com/methodology