# K071370: Nobelactive Internal Connection Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Aug 3, 2007 after 79 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 21 ancestors in all.
414 later devices descend from it; 29 cite it directly.
0 of 436 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061003: SFB & CFB Implants, Nobel Biocare AB (2006) Summary page 1.

## Most influential descendants
- K101732: Astra Tech Implant System (2011), 214 descendants of its own
- K102436: Nobel Active 3.0 (2010), 203 descendants of its own
- K111287: Astra Tech Implant System (2011), 201 descendants of its own
- K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant (2011), 200 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own

## Recalls of this device
- Aug 9, 2019 · Class II · Z-1855-2020: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened
- Aug 9, 2019 · Class II · Z-1854-2020: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened
- Jul 19, 2019 · Class II · Z-2207-2020: The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). 
- May 28, 2019 · Class II · Z-2250-2020: Packaged dental implant healing abutments were found to contain the wrong size device.

## 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.

Source page: https://510kreport.com/device/K071370
Methodology: https://510kreport.com/methodology