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FDA 510(k)

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments

K-Number: K212785 · 2022-06-30

Decision Date2022-06-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments is a medical device manufactured by Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2022-06-30 under approval number K212785. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments?

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K212785.

When was Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments approved by the FDA?

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments received FDA 510(k) clearance on 2022-06-30, under approval number K212785.

What company makes Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments?

Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments is manufactured by Blue Sky Bio, LLC.

What is the FDA product code for Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments?

The FDA product code for Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments is DZE.

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Official Source

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