Cleared Traditional

K260527 - FACE4D Aligner

K260527 is an FDA 510(k) clearance for FACE4D Aligner, manufactured by Avinent Implant System S.L.U.. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K260527 · Avinent Implant System S.L.U. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
135d
Days
Class 2
Risk

K260527 is an FDA 510(k) clearance for the FACE4D Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Avinent Implant System S.L.U. (Barcelona, ES). The FDA issued a Cleared decision on July 2, 2026 after a review of 135 days - within the typical 510(k) review window.

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 Avinent Implant System S.L.U. devices

FDA 510(k) Submission Details - K260527

510(k) Number K260527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2026
Decision Date July 02, 2026
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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.

Regulatory Consultant

Blackwell Device Consulting
Angela Blackwell

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 137
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K260527.
Smylio Aligners
K260788 · Smylio, Inc. · May 2026
SureSmile Aligner (ASSY500020)
K260722 · Dentsply Sirona, Inc. · Apr 2026
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Primeprint Direct Aligner
K250739 · Dreve Dentamid GmbH · Nov 2025
Invisalign® Palatal Expander System
K252931 · Align Technology, Inc. · Oct 2025