# K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Jun 30, 2022 after 302 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: 11 generations back to K925765 (1993). 73 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190958: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 4.

## Most influential descendants
- K252168: Straumann® BLC Implants - Indication Widening (2026), 0 descendants of its own
- K252090: Pterygoid Indication for GM Helix Implants (2025), 0 descendants of its own
- K232726: External Hex Implant System (2024), 0 descendants of its own

## Indications for use
Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multi-unit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45º angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45º angulation are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K212785
Methodology: https://510kreport.com/methodology