Cleared Traditional

K220894 - SmileGuard (FDA 510(k) Clearance)

K220894 · Envisiontec GmbH · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2022
Decision
74d
Days
-
Risk

K220894 is an FDA 510(k) clearance for the SmileGuard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on June 10, 2022 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Envisiontec GmbH devices

Submission Details

510(k) Number K220894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2022
Decision Date June 10, 2022
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Qserve Group, Us, Inc.
Patsy J Trisler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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