Cleared Traditional

Ohlendorf Clear Aligner (K210540) - FDA 510(k) Clearance

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

K210540 · Ohlendorf Appliance Laboratory · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
84d
Days
Class 2
Risk

K210540 is an FDA 510(k) clearance for the Ohlendorf Clear Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Ohlendorf Appliance Laboratory (St. Louis, US). The FDA issued a Cleared decision on May 19, 2021 after a review of 84 days - a notably fast clearance cycle.

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: 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 Ohlendorf Appliance Laboratory devices

Submission Details

510(k) Number K210540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2021
Decision Date May 19, 2021
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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

Trisler Consulting
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 - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K210540.
TRIOCLEAR System
K193622 · Perfection Aligner System Hong Kong Limited · Jul 2021
HIT Clear Aligner
K210613 · Cdb Corporation · Jun 2021
6MS Invisible Aligner
K210652 · Sms Opco, LLC · Jun 2021
Illusion Aligners
K211010 · Laxmi Dental Exports Pvt, Ltd. · Apr 2021
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
K211190 · 3M Company, Unitek Orthodontic Products · Apr 2021
Spark Clear Aligner System
K203737 · Ormco Corporation · Mar 2021