Cleared Traditional

K211427 - CREOKORREKT Aligners (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211427 · Creodent Prosthetics, Ltd. · Dental device
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Oct 2022
Decision
524d
Days
Class 2
Risk

K211427 is an FDA 510(k) clearance for the CREOKORREKT Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Creodent Prosthetics, Ltd. (New York, US). The FDA issued a Cleared decision on October 13, 2022 after a review of 524 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Creodent Prosthetics, Ltd. devices

Submission Details

510(k) Number K211427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2021
Decision Date October 13, 2022
Days to Decision 524 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
397d slower than avg
Panel avg: 127d · This submission: 524d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Withus Group, Inc.
April Lee

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 - NXC Aligner, Sequential

All 142
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