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Blue Sky Bio Zygomatic Implant System — Blue Sky Bio, LLC (510(k) K190491)

Blue Sky Bio Zygomatic Implant System — Blue Sky Bio, LLC (510(k) K190491) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Blue Sky Bio Zygomatic Implant System; Applicant: Blue Sky Bio, LLC; Clearance track: 510(k).

Device nameBlue Sky Bio Zygomatic Implant System
ApplicantBlue Sky Bio, LLC
Clearance track510(k)
Submission numberK190491
DecisionSubstantially Equivalent
Decision date2019-08-12
Date received2019-02-28
Product codeNHA
Device class2
Medical specialtyDental
Applicant locationIL, US
SourceopenFDA device

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