Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Blue Sky Bio with 21 510(k) clearances. The most recent is a 510(k) clearance dated Apr 3, 2024: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 3, 2024 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXK232653 · NXC | 510(k) clearances |
| Feb 24, 2023 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GK221845 · NXC | 510(k) clearances |
| Jun 30, 2022 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsK212785 · DZE | 510(k) clearances |
| Dec 18, 2020 | Blue Sky Bio CAD-CAM AbutmentsK202026 · NHA | 510(k) clearances |
| Dec 17, 2020 | Blue Sky Bio TADK201919 · OAT | 510(k) clearances |
| Aug 12, 2019 | Blue Sky Bio Zygomatic Implant SystemK190491 · NHA | 510(k) clearances |
| Nov 9, 2018 | Blue Sky Bio Computerized Orthodontic Bracket SystemK182338 · DYW | 510(k) clearances |
| Feb 9, 2018 | Blue Sky Bio AlignerK180107 · NXC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
