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510(k) K221845

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G by Blue Sky Bio, LLC — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2023
Date Received
June 24, 2022
Clearance Type
Abbreviated
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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  • 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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