# K202026: Blue Sky Bio CAD-CAM Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio, LLC
- Decided: Dec 18, 2020 after 149 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K960026 (1996). 321 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 333 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191986: DESS Dental Smart Solutions, Terrats Medical SL (2019) Summary page 4.

## Most influential descendants
- K212108: Dynamic TiBase (2021), 9 descendants of its own
- K221966: Dynamic TiBase (2022), 5 descendants of its own
- K232151: Dynamic TiBase (2023), 2 descendants of its own
- K231559: Multi-Unit DAS System (2023), 1 descendant of its own
- K221673: Bonafix TiBase (2023), 1 descendant of its own

## Indications for use
Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.

Source page: https://510kreport.com/device/K202026
Methodology: https://510kreport.com/methodology