# K102436: Nobel Active 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Dec 9, 2010 after 105 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: 8 generations back to K894595 (1990). 22 ancestors in all.
203 later devices descend from it; 14 cite it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.

## Most influential descendants
- K142260: NobelActive (2015), 99 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K111421: Sirona Dental Cad/Cam System (2012), 54 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K132209: Ips E.Max Cad Abutment Solutions (2013), 39 descendants of its own

## Indications for use
The NobelActive. 3.0mm implant Is indicated for use In the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

Source page: https://510kreport.com/device/K102436
Methodology: https://510kreport.com/methodology