# K041876: Nobeldirect OD Implant

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Aug 20, 2004 after 39 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 K022562 (2002). 2 ancestors in all.
188 later devices descend from it; 2 cite it directly.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 1.
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite, Nobel Biocare Uas, Inc. (2003) Summary page 1.

## Most influential descendants
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 descendants of its own

## Indications for use
The NobelDirect TM OD Implant is a root form endosseous implant intended to provide immediate retention for a removable tissue-supported overdenture. The NobelDirect OD Implant is used in the intra-foraminal area of the anterior mandible for the fully edentulous lower arch.

Source page: https://510kreport.com/device/K041876
Methodology: https://510kreport.com/methodology