# K031345: Nobel Direct, Models 30937, 30938

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Jul 24, 2003 after 86 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: 1 generation back to K023952 (2003). 1 ancestor in all.
94 later devices descend from it; 5 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite, Nobel Biocare Uas, Inc. (2003) Summary page 1.

## Most influential descendants
- K070857: Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM (2007), 43 descendants of its own
- K050506: Primasolo One-Piece Implants & Healing Caps (2005), 43 descendants of its own
- K080594: MS System (Narrow Ridge) (2008), 42 descendants of its own
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics (2005), 40 descendants of its own
- K182091: Osstem Abutment System (2019), 30 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 incisols to supporl prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. 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/K031345
Methodology: https://510kreport.com/methodology