Cleared Traditional

E-Guard (K201173) - FDA 510(k) Clearance

K201173 · Envisiontec GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
210d
Days
-
Risk

K201173 is an FDA 510(k) clearance for the E-Guard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on November 27, 2020 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Envisiontec GmbH devices

Submission Details

510(k) Number K201173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date November 27, 2020
Days to Decision 210 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
83d slower than avg
Panel avg: 127d · This submission: 210d
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.

Regulatory Peers - MQC Mouthguard, Prescription

All 40
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