Home / 510(k) Clearances / K201919

510(k) K201919

Blue Sky Bio TAD by Blue Sky Bio, LLC — Product Code OAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2020
Date Received
July 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Orthodontic
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Other clearances by Blue Sky Bio, LLC

  • 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)
  • 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)

Other clearances for product code OAT

  • K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device) (June 19, 2025)
  • K231502 — Mini Screws (September 4, 2024)
  • K231913 — T-FIT (February 8, 2024)
  • K222245 — ACR Screw System (August 21, 2023)
  • K202163 — Mico One Orthodontic Screw (October 7, 2022)
  • K202691 — Ortholock Anchorage Devices (April 28, 2022)
  • K210559 — ATOZ Mini-Screw (December 19, 2021)
  • K211992 — Ortho MI System (October 15, 2021)
  • K202790 — Syntec Orthodontic Mini Screw Extended System (September 17, 2021)
  • K202278 — OBS Anchorage Screw, Biokey Anchorage Screw (January 8, 2021)