Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SmileGuard

K-Number: K220894 · 2022-06-10

Decision Date2022-06-10
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

SmileGuard is a medical device manufactured by Envisiontec GmbH. It received FDA 510(k) clearance on 2022-06-10 under approval 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. It is manufactured by Envisiontec GmbH. The 510(k) number is K220894.

When was SmileGuard approved by the FDA?

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

What company makes SmileGuard?

SmileGuard is manufactured by Envisiontec GmbH.

What is the FDA product code for SmileGuard?

The FDA product code for SmileGuard is MQC.

Other Devices by Envisiontec GmbH

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.