K-number	K181416
Device name	Sapphire Dorsal Comfort Fit
Applicant	Crane Dental Laboratory, Inc.
Product code	LRK
Device class	Class II
Decision date	Sep 17, 2019
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Sapphire Dorsal Comfort Fit

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