# K083100: Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RP

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare USA, LLC
- Decided: Nov 19, 2008 after 30 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: 9 generations back to K894595 (1990). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 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.
- K972475: Auradapt Aubtment System, Nobel Biocare Uas, Inc. (1997) Summary page 1.
- K072129: Nobelactive Zirconia Abutment, Nobel Biocare AB (2008) Summary page 1.

## Most influential descendants
- K112259: Nobelactive 3.0 Goldadapt Abutments (2011), 0 descendants of its own

## Indications for use
Nobel Biocare's NobelActive implants are endosseous implant 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 NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K083100
Methodology: https://510kreport.com/methodology