Cleared Traditional

K180241 - Orthocaps Twinaligner

K180241 is the FDA 510(k) clearance for Orthocaps Twinaligner by Ortho Caps GmbH. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K180241 · Ortho Caps GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Ortho Caps GmbH devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 127d · 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 Consultant

Rmo, Inc.
Angelica Ayala

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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K180241.
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Smylic Invisible Clear Aligners
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Smart Moves Complete
K172765 · Great Lakes Orthodontics, Ltd. · Jun 2018
Custom Clear Aligner System
K173785 · Derby Dental Laboratory · Mar 2018