Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (K221845)
Description
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G by Blue Sky Bio, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221845
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (K221845) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223355 | Tera Harz Clear | Graphy, Inc. | 2022 |
| K192244 | Arcad SmileStudio and Aligner System | Arcadlab | 2020 |
| K180107 | Blue Sky Bio Aligner | Blue Sky Bio, LLC | 2018 |
Trace the full predicate network for K221845
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.