# K070857: Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Dec 28, 2007 after 275 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: 2 generations back to K023952 (2003). 2 ancestors in all.
43 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031345: Nobel Direct, Models 30937, 30938, Nobel Biocare Uas, Inc. (2003)

## Most influential descendants
- K080594: MS System (Narrow Ridge) (2008), 42 descendants of its own
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K083067: MS System (2009), 7 descendants of its own

## Indications for use
The Nobel Direct 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 NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Source page: https://510kreport.com/device/K070857
Methodology: https://510kreport.com/methodology