Cleared Abbreviated

NextDent Ortho Flex (K221022) - FDA 510(k) Clearance

K221022 · Vertex-Dental B.V. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
198d
Days
-
Risk

K221022 is an FDA 510(k) clearance for the NextDent Ortho Flex. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Vertex-Dental B.V. (Soesterberg, NL). The FDA issued a Cleared decision on October 21, 2022 after a review of 198 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vertex-Dental B.V. devices

Submission Details

510(k) Number K221022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2022
Decision Date October 21, 2022
Days to Decision 198 days
Submission Type Abbreviated
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
71d slower than avg
Panel avg: 127d · This submission: 198d
Pathway characteristics
Standards-based clearance path.

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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