# K081128: Molar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Nov 7, 2008 after 200 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 1.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 1.
- K050258: Groovy Implants, Nobel Biocare AB (2005) Summary page 1.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.

## Indications for use
Nobel Biocare's Molar Implants are endosseous dental implants 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. The Molar Implants are indicated for single or multiple unit restorations in the molar region. The Molar Implants can be used in splinted or non-splinted applications. The Molar 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/K081128
Methodology: https://510kreport.com/methodology