# K153064: Blue Sky Bio Zygomatic Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Apr 29, 2016 after 190 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: 14 generations back to K960026 (1996). 145 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141777: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 5.
- K102034: Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2011) Summary page 5.
- K060957: Modification to Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2006) Summary page 5.
- K093562: Endosseous Dental Implant, Southern Implants, Inc. (2010) Summary page 5.

## Most influential descendants
- K190491: Blue Sky Bio Zygomatic Implant System (2019), 0 descendants of its own

## Indications for use
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K153064
Methodology: https://510kreport.com/methodology