Blue Sky Bio TAD
K-Number: K201919 · 2020-12-17
ApplicantBlue Sky Bio, LLC
Decision Date2020-12-17
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Blue Sky Bio TAD is a medical device manufactured by Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2020-12-17 under approval number K201919. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Blue Sky Bio TAD?
Blue Sky Bio TAD is a medical device that received FDA 510(k) clearance on 2020-12-17. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K201919.
When was Blue Sky Bio TAD approved by the FDA?
Blue Sky Bio TAD received FDA 510(k) clearance on 2020-12-17, under approval number K201919.
What company makes Blue Sky Bio TAD?
Blue Sky Bio TAD is manufactured by Blue Sky Bio, LLC.
What is the FDA product code for Blue Sky Bio TAD?
The FDA product code for Blue Sky Bio TAD is OAT.
Other Devices by Blue Sky Bio, LLC
K153064Blue Sky Bio Zygomatic Implant System
K180107Blue Sky Bio Aligner
K190491Blue Sky Bio Zygomatic Implant System
K202026Blue Sky Bio CAD-CAM Abutments
K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Related Devices (Code: OAT)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.