# K112259: Nobelactive 3.0 Goldadapt Abutments

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare AB
- Decided: Oct 28, 2011 after 81 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894595 (1990). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 1.
- K083100: Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RP, Nobel Biocare USA, LLC (2008) Summary page 1.

## 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/K112259
Methodology: https://510kreport.com/methodology