# K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Jan 16, 2003 after 50 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
No predicates in its family tree.
295 later devices descend from it; 6 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041876: Nobeldirect OD Implant (2004), 188 descendants of its own
- 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

## Indications for use
The Replace@One Piece Implant is a threaded one-piece implant with an integrated abutment, designed for single-stage surgical procedure and cemented restorations. The Replace One Piece Implant is intended for immediate load on single tooth and multiple tooth applications in good quality bone, to restore chewing hnction.

Source page: https://510kreport.com/device/K023952
Methodology: https://510kreport.com/methodology