SmileGuard— 510(k) K220894

Name: FDA 510(k) clearance K220894
Creator: U.S. Food and Drug Administration
Published: 2022-06-10

Substantially Equivalent

Envisiontec GmbH

FDA 510(k) clearance K220894 for SmileGuard, Substantially Equivalent on 2022-06-10. Applicant: Envisiontec GmbH. Device class: Unclassified.

Clearance details

Applicant: Envisiontec GmbH
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-03-28
Decision date: 2022-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gladbeck, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.