Cleared Traditional

K180241 - Orthocaps Twinaligner (FDA 510(k) Clearance)

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

K180241 · Ortho Caps GmbH · Dental device
Sep 2018
Decision
242d
Days
Class 2
Risk

K180241 is an FDA 510(k) clearance for the Orthocaps Twinaligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Ortho Caps GmbH (Hamm 59069, DE). The FDA issued a Cleared decision on September 28, 2018 after a review of 242 days - an extended review 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: 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.

Submission Details

510(k) Number K180241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date September 28, 2018
Days to Decision 242 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 158d · This submission: 242d
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 Peers - NXC Aligner, Sequential

All 13
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K180241.
ZSmile System
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Invisalign® Palatal Expander System
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Serafin®
K251758 · Tns Co., Ltd. · Sep 2025