# K051507: Modification to Blue Sky Bio Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Sep 2, 2005 after 87 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102034: Blue Sky Bio Dental Implant System (2011), 4 descendants of its own
- K213576: Tatum Surgical Dental Implant System (2022), 1 descendant of its own
- K153064: Blue Sky Bio Zygomatic Implant System (2016), 1 descendant of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own
- K190491: Blue Sky Bio Zygomatic Implant System (2019), 0 descendants of its own

## Indications for use
For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis For single stage or two stage surgical procedure One piece implants for single stage procedure only For immediate placement and immediate function when multiple units are splinted and for single units when adequate initial stability is achieved in type I or type 11 bone and under appropriate ocClusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prostlhesis. four or more implants must be used.

Source page: https://510kreport.com/device/K051507
Methodology: https://510kreport.com/methodology