# K133733: WINSIX Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biosaf IN S.R.L.
- Decided: Jan 28, 2015 after 418 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: 9 generations back to K925765 (1993). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073458: BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2), Btlock Srl (2008) Summary page 4.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 4.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 4.
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 4.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 4.
- K033922: Modification to Iti Dental Implant System, Institut Straumann AG (2004) Summary page 4.
- K073628: Synocta Abutments, Straumann USA (2008) Summary page 5.
- K061477: Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems, Nobel Biocare AB (2006) Summary page 5.

## Indications for use
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K133733
Methodology: https://510kreport.com/methodology