K-number	K182338
Device name	Blue Sky Bio Computerized Orthodontic Bracket System
Applicant	Blue Sky Bio
Product code	DYW
Device class	Class II
Decision date	Nov 9, 2018
Decision	Substantially Equivalent
Regulation	872.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Blue Sky Bio Computerized Orthodontic Bracket System

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