Chrysalis Intelligence · Sponsors · Blue Sky Bio, LLC

Blue Sky Bio, LLC

Libertyville, IL, US · 5 510(k) clearances

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Total clearances
5
2020-12-17 → 2024-04-03
Last 12 months
0
Product codes
4
Most recent
2024-04-03
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NXC Aligner, Sequential Class II Dental 2 2024-04-03
DZE Implant, Endosseous, Root-Form Class II Dental 1 2022-06-30
NHA Abutment, Implant, Dental, Endosseous Class II Dental 1 2020-12-18
OAT Implant, Endosseous, Orthodontic Class II Dental 1 2020-12-17
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2024-04-03 K232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX NXC Class II Dental
2023-02-24 K221845 Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G NXC Class II Dental
2022-06-30 K212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments DZE Class II Dental
2020-12-18 K202026 Blue Sky Bio CAD-CAM Abutments NHA Class II Dental
2020-12-17 K201919 Blue Sky Bio TAD OAT Class II Dental
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence