Cleared Traditional

SmileGuard (K220894) - FDA 510(k) Clearance

K220894 · Envisiontec GmbH · Dental device
Download Printable Device Report (PDF)
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.

Regulatory Peers - MQC Mouthguard, Prescription

All 40
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K220894.
Glidewell TuffSplint™ Appliance Resin
K223798 · Prismatik Dentalcraft, Inc. · Feb 2023
Dental LT Clear V2 Resin
K222061 · Formlabs Ohio, Inc. · Nov 2022
NextDent Ortho Flex
K221022 · Vertex-Dental B.V. · Oct 2022
Thermeo System
K212017 · Pro3dure Medical GmbH · Apr 2022
Glidewell Appliance Resin, Hard/Soft
K214102 · Prismatik Dentalcraft, Inc. · Feb 2022
SleepRight Select-Comfort Dental Guard
K212767 · Splintek, Inc. · Dec 2021