# K023113: Replace Tiunite Endosseous Implant

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Sep 26, 2002 after 7 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894595 (1990). 10 ancestors in all.
689 later devices descend from it; 17 cite it directly.
0 of 700 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 1.

## Most influential descendants
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own
- K050705: Tiunite Implants (2005), 532 descendants of its own
- K050258: Groovy Implants (2005), 511 descendants of its own
- K061003: SFB & CFB Implants (2006), 507 descendants of its own
- K071370: Nobelactive Internal Connection Implant (2007), 414 descendants of its own

## Recalls of this device
- Mar 9, 2015 · Class II · Z-1432-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1419-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1437-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1416-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1425-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1427-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1438-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1440-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1431-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..
- Mar 9, 2015 · Class II · Z-1426-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1421-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1415-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1436-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1417-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1439-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1429-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1424-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1435-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1422-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1418-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1414-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1428-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1430-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1420-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1423-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1434-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Mar 9, 2015 · Class II · Z-1433-2015: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

## Indications for use
The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore patient's chewing function. This may be accomplished using a two stage surgical procedure or a single stage surgical procedure. If the single stage surgical procedure is used, these implants may be loaded immediately following insertion - provided - at least four implants are placed and splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foraminae) where good initial stability of the implants with or without bi-cortical anchorage, can most often be obtained.

Source page: https://510kreport.com/device/K023113
Methodology: https://510kreport.com/methodology