Home / 510(k) Clearances / K182338

510(k) K182338

Blue Sky Bio Computerized Orthodontic Bracket System by Blue Sky Bio — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2018
Date Received
August 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

Other clearances by Blue Sky Bio

  • K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (April 3, 2024)
  • K221845 — Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (February 24, 2023)
  • 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)
  • 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)

Other clearances for product code DYW

  • K252760 — Carriere® Motion Pro® Clear Bite Corrector (November 27, 2025)
  • K251196 — Composite Orthodontic Brackets and Buttons (April 21, 2025)
  • K201940 — Braces on Demand Bracket (December 3, 2020)
  • K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (October 30, 2018)
  • K160720 — Carriere Motion Clear Class II (November 28, 2016)
  • K150830 — CompleClear Plastic Orthodontic Bracket and Wire Appliance (August 26, 2016)
  • K150702 — Exceed Tx (March 24, 2016)
  • K140807 — COMPOSITE ORTHODONTIC BRACKETS (November 12, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)