# K073713: Blue Sky Bio Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Mar 28, 2008 after 88 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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 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 II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used. Abutments are intended for use in conjunction with compatible Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restoration.

Source page: https://510kreport.com/device/K073713
Methodology: https://510kreport.com/methodology