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FDA 510(k)

Glidewell Appliance Resin, Hard/Soft

K-Number: K214102 · 2022-02-23

Decision Date2022-02-23
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Glidewell Appliance Resin, Hard/Soft is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2022-02-23 under approval number K214102. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Glidewell Appliance Resin, Hard/Soft?

Glidewell Appliance Resin, Hard/Soft is a medical device that received FDA 510(k) clearance on 2022-02-23. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K214102.

When was Glidewell Appliance Resin, Hard/Soft approved by the FDA?

Glidewell Appliance Resin, Hard/Soft received FDA 510(k) clearance on 2022-02-23, under approval number K214102.

What company makes Glidewell Appliance Resin, Hard/Soft?

Glidewell Appliance Resin, Hard/Soft is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for Glidewell Appliance Resin, Hard/Soft?

The FDA product code for Glidewell Appliance Resin, Hard/Soft is MQC.

Other Devices by Prismatik Dentalcraft, Inc.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.