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FDA 510(k)

Glidewell Appliance Resin, Hard/Soft

K-Number: K214102 · 2022-02-23

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2022-02-23
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Glidewell Appliance Resin, Hard/Soft is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) 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. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K214102.

When did Glidewell Appliance Resin, Hard/Soft receive FDA 510(k) clearance?

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

Who is the listed applicant for Glidewell Appliance Resin, Hard/Soft?

The FDA 510(k) record lists Prismatik Dentalcraft, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: MQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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