Glidewell TuffSplint Appliance Resin
K-Number: K223798 · 2023-02-17
ApplicantPrismatik Dentalcraft, Inc.
Decision Date2023-02-17
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
Glidewell TuffSplint Appliance Resin is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-02-17 under approval number K223798. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Glidewell TuffSplint Appliance Resin?
Glidewell TuffSplint Appliance Resin is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K223798.
When was Glidewell TuffSplint Appliance Resin approved by the FDA?
Glidewell TuffSplint Appliance Resin received FDA 510(k) clearance on 2023-02-17, under approval number K223798.
What company makes Glidewell TuffSplint Appliance Resin?
Glidewell TuffSplint Appliance Resin is manufactured by Prismatik Dentalcraft, Inc..
What is the FDA product code for Glidewell TuffSplint Appliance Resin?
The FDA product code for Glidewell TuffSplint Appliance Resin is MQC.
Other Devices by Prismatik Dentalcraft, Inc.
Related Devices (Code: MQC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.