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510(k) K232653

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX by Blue Sky Bio, LLC — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2024
Date Received
August 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aligner, Sequential
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other clearances by Blue Sky Bio, LLC

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  • K212785 — Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sk (June 30, 2022)
  • K202026 — Blue Sky Bio CAD-CAM Abutments (December 18, 2020)
  • K201919 — Blue Sky Bio TAD (December 17, 2020)
  • K190491 — Blue Sky Bio Zygomatic Implant System (August 12, 2019)
  • K182338 — Blue Sky Bio Computerized Orthodontic Bracket System (November 9, 2018)
  • K180107 — Blue Sky Bio Aligner (February 9, 2018)
  • K163251 — Life Essence Universal Porcelain System (August 4, 2017)
  • K153064 — Blue Sky Bio Zygomatic Implant System (April 29, 2016)
  • K112875 — BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS (January 27, 2012)

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  • K252380 — Invisalign System (August 29, 2025)
  • K251415 — Additively Manufactured Aligner Resin (August 27, 2025)
  • K251616 — Clear Miracle (July 22, 2025)
  • K242637 — MEM Clear Aligner System (May 21, 2025)