# K131345: Tiarray Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Nasseo, Inc.
- Decided: Aug 7, 2013 after 90 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: 8 generations back to K894595 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061003: SFB & CFB Implants, Nobel Biocare AB (2006) Summary page 2.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 2.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 2.

## Indications for use
The TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Source page: https://510kreport.com/device/K131345
Methodology: https://510kreport.com/methodology