# K112875: Blue Sky Bio Dental Taper Hex Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Jan 27, 2012 after 119 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: 1 generation back to K073713 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080396: Osseospeed Narrow, Astra Tech AB (2008) Summary page 2.
- K073713: Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC (2008) Summary page 3.

## Indications for use
Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular incisors and maxillary lateral incisors Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws Implants can be placed in immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multi-unit abutments for fixed restorations are to be used only for multiple splinted restorations. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Blue Sky Bio 3mm Double Hex Dental Implants are compatible with Astra Osseospeed Narrow abutments. Blue Sky Bio 3mm Double Hex Abutments are compatible with Astra Osseospeed Narrow Implants.

Source page: https://510kreport.com/device/K112875
Methodology: https://510kreport.com/methodology