# K050705: Tiunite Implants

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: May 19, 2005 after 62 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894595 (1990). 18 ancestors in all.
532 later devices descend from it; 10 cite it directly.
0 of 551 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041661: Nobel Biocare Endosseous Implants, Nobel Biocare Uas, Inc. (2004) Summary page 1.

## Most influential descendants
- K061003: SFB & CFB Implants (2006), 507 descendants of its own
- K071370: Nobelactive Internal Connection Implant (2007), 414 descendants of its own
- K062749: SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model 33701, CFB 15 Esthetic Abutment 2MM (2006), 327 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own

## Recalls of this device
- Nov 2, 2007 · Not classified · Z-2240-2008: This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the im

## Indications for use
Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare TiUnite Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. TiUnite® implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite® implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.

Source page: https://510kreport.com/device/K050705
Methodology: https://510kreport.com/methodology