K-number	K223798
Device name	Glidewell TuffSplint Appliance Resin
Applicant	Prismatik Dentalcraft, Inc.
Product code	MQC
Device class	Class U
Decision date	Feb 17, 2023
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Glidewell TuffSplint Appliance Resin

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Glidewell TuffSplint Appliance Resin