Cleared Traditional

K073121 - NUBRACE INVISIBLE REMOVABLE ORTHODONTICS

K073121 is an FDA 510(k) clearance for NUBRACE INVISIBLE REMOVABLE ORTHODONTICS, manufactured by Nubrace, Inc.. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K073121 · Nubrace, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
465d
Days
Class 2
Risk

K073121 is an FDA 510(k) clearance for the NUBRACE INVISIBLE REMOVABLE ORTHODONTICS. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Nubrace, Inc. (Washington, US). The FDA issued a Cleared decision on February 12, 2009 after a review of 465 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 Nubrace, Inc. devices

FDA 510(k) Submission Details - K073121

510(k) Number K073121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2007
Decision Date February 12, 2009
Days to Decision 465 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 127d · This submission: 465d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXC Device Classification - Class 2, Special Controls

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.