FDA 510(k)

SmileGuard

K-Number: K220894 · 2022-06-10

Decision Date2022-06-10

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

SmileGuard is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K220894. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmileGuard?

SmileGuard is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Envisiontec GmbH. The 510(k) number is K220894.

When did SmileGuard receive FDA 510(k) clearance?

SmileGuard received FDA 510(k) clearance on 2022-06-10, under 510(k) number K220894.

Who is the listed applicant for SmileGuard?

The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmileGuard?

The FDA product code for SmileGuard is MQC.

Other records listing Envisiontec GmbH as applicant

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.

K211101E-Temp K210977E-Dent 1000 K203641E-Denture Pro K201173E-Guard

Related Devices (Code: MQC)

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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.