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SmileGuard

Envisiontec GmbH · Model RES-01-3194 · UDI-DI 04260683220652

KMY MQC Prescription

510(k) clearances

1,679

Adverse events

Recalls

112

Facilities

Description

SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.