Cleared Traditional

K200005 - Concinnity Aligners

K200005 is the FDA 510(k) clearance for Concinnity Aligners by Drake Precision Dental Laboratory, Inc.. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K200005 · Drake Precision Dental Laboratory, Inc. · Dental device
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Nov 2020
Decision
312d
Days
Class 2
Risk

K200005 is an FDA 510(k) clearance for the Concinnity Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Drake Precision Dental Laboratory, Inc. (Charlotte, US). The FDA issued a Cleared decision on November 9, 2020 after a review of 312 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Drake Precision Dental Laboratory, Inc. devices

Submission Details

510(k) Number K200005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2020
Decision Date November 09, 2020
Days to Decision 312 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
185d slower than avg
Panel avg: 127d · This submission: 312d
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

Bdra Consulting, LLC
Srinagesh Koushik

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 K200005.
ClearPath Aligner
K202857 · Clearpath Orthodontics, Ltd. · Jan 2021
iSMILE
K200908 · 3D Diagnostix, Inc. · Dec 2020
TP Orthodontics Clear Aligner System
K193385 · Tp Orthodontics, Inc. · Nov 2020
Eon Aligner
K202685 · Eon Dental Jordan, LLC · Sep 2020
Straight T Clear Dental Aligner
K201450 · Straight T, Inc. · Sep 2020
MVP Aligner System
K193130 · Mvp Aligners, LLC · Aug 2020