# K182338: Blue Sky Bio Computerized Orthodontic Bracket System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Sky Bio
- Decided: Nov 9, 2018 after 73 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K151702: Reusable Full Silicone Cover, Laerdal Medical AS (2015). Our reading of the summary gave K151702, FDA’s number for Reusable Full Silicone Cover (Laerdal Medical AS). Its FDA name has none of the distinctive words the summary uses for the device it names, “Exceed Computerized Precision Bracket Placement Solution”. Kept off the family tree. Summary page 7.

## Indications for use
Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time.

Source page: https://510kreport.com/device/K182338
Methodology: https://510kreport.com/methodology