Blue Sky Bio Aligner
K-Number: K180107 · 2018-02-09
ApplicantBlue Sky Bio, LLC
Decision Date2018-02-09
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Blue Sky Bio Aligner is a medical device manufactured by Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2018-02-09 under approval number K180107. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Blue Sky Bio Aligner?
Blue Sky Bio Aligner is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K180107.
When was Blue Sky Bio Aligner approved by the FDA?
Blue Sky Bio Aligner received FDA 510(k) clearance on 2018-02-09, under approval number K180107.
What company makes Blue Sky Bio Aligner?
Blue Sky Bio Aligner is manufactured by Blue Sky Bio, LLC.
What is the FDA product code for Blue Sky Bio Aligner?
The FDA product code for Blue Sky Bio Aligner is NXC.
Other Devices by Blue Sky Bio, LLC
K153064Blue Sky Bio Zygomatic Implant System
K190491Blue Sky Bio Zygomatic Implant System
K202026Blue Sky Bio CAD-CAM Abutments
K201919Blue Sky Bio TAD
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: NXC)
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.