# K190491: Blue Sky Bio Zygomatic Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Aug 12, 2019 after 165 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K960026 (1996). 146 ancestors in all.
No later device cites it as a predicate yet.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153064: Blue Sky Bio Zygomatic Implant System, Blue Sky Bio, LLC (2016) Summary page 4.

## 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/K190491
Methodology: https://510kreport.com/methodology