Cleared Traditional

K182658 - Bioliner

K182658 is the FDA 510(k) clearance for Bioliner by Five Star Orthodontic Lab & Supply. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K182658 · Five Star Orthodontic Lab & Supply · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
267d
Days
Class 2
Risk

K182658 is an FDA 510(k) clearance for the Bioliner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Five Star Orthodontic Lab & Supply (Denton, US). The FDA issued a Cleared decision on June 19, 2019 after a review of 267 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 Five Star Orthodontic Lab & Supply devices

Submission Details

510(k) Number K182658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2018
Decision Date June 19, 2019
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K182658.
3M Clarity Aligners
K192119 · 3M Company · Sep 2019
OSW Aligner System
K191990 · Osw Manufacturing, LLC · Aug 2019
DynaFlex
K190583 · Dyna Flex · Jun 2019
Argen Clear Aligner
K183229 · Argen Corporation · Jun 2019
Magic Clear Aligners
K190948 · Voodoo Manufacturing, Inc. · May 2019
Orthodontic Appliance
K181747 · Shandong Huge Dental Material Corporation · Apr 2019