# K142846: BBX1, BBX2, BBX1MO, BBX1MC

- Pathway: 510(k) (Traditional)
- Applicant: Globaldental, Inc.
- Decided: Sep 8, 2016 after 709 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 K944964 (1995). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033392: Immediate Stabilizing Implant (Isi), O Co., Inc. (2003) Summary page 5.
- K090174: Tsi; Eri, Oco Biomedical (2009) Summary page 5.

## Indications for use
BBX1, BBX2, BBX1MO,BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient’s chewing function.

Source page: https://510kreport.com/device/K142846
Methodology: https://510kreport.com/methodology