# K073458: BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2)

- Pathway: 510(k) (Traditional)
- Applicant: Btlock Srl
- Decided: Apr 4, 2008 after 116 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 K925765 (1993). 69 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 72 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.
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.

## Most influential descendants
- K133733: WINSIX Implant System (2015), 0 descendants of its own
- K083869: BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S)  Dddiii BTICV3, 1, and Dddiiibtisi (2009), 0 descendants of its own

## Indications for use
BT-Tite Standard (or VSM) It is intended to be used in maxilla or mandible, and for every kind of reconstruction, preferably not immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. BT-Tite One (or CV1) It is -intended to be used in maxilla or mandible, for extraction sites and where the implant would be immediately loaded. It is intended to be used in a single stage or two stage surgical procedure. BT-Tite CV2 (or CV2) It is intended to be used in maxilla or mandible. It is indicated in any situation for extraction sites, where the implant would be immediately loaded and where the bone crest is stable. In case of post-extraction sites, it has to be inserted some millimetres under the bone. It is intended to be used in a single stage or two stage surgical procedure.

Source page: https://510kreport.com/device/K073458
Methodology: https://510kreport.com/methodology