# K102034: Blue Sky Bio Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Apr 19, 2011 after 274 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 K894595 (1990). 36 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051507: Modification to Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2005) Summary page 1.
- K060957: Modification to Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2006) Summary page 1.
- K063874: Drill for Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2007) Summary page 4.
- K073713: Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2008) Summary page 1.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 4.
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 5.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 4.

## Most influential descendants
- 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
Intended Use for Two-Piece Implant Systems *For implantation into any area of the fully 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 11 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. *Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. *Taper Hex Implant System is compatible with NobelActive implants and prosthetics *Double Hex Implant System is compatible with Astra double hex implants and prosthetics *Square Taper Implant System is compatible with Straumann Bone-Level implants and prosthetics Intended Use for One-Piece Implant System *For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis *For single tooth or multiple unit prosthesis *For single 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 11 bone and under appropriate occlusal loading. In edentulous cases four or more implants must be used *Overdenture Implants are intended for support of removable prosthesis.

Source page: https://510kreport.com/device/K102034
Methodology: https://510kreport.com/methodology