Cleared Abbreviated

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (K221845) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K221845 · Blue Sky Bio, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
245d
Days
Class 2
Risk

K221845 is an FDA 510(k) clearance for the Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Blue Sky Bio, LLC (Libertyville, US). The FDA issued a Cleared decision on February 24, 2023 after a review of 245 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Blue Sky Bio, LLC devices

Submission Details

510(k) Number K221845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2022
Decision Date February 24, 2023
Days to Decision 245 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
Pathway characteristics
Standards-based clearance path.

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 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K221845.
Custom-made Invisible Aligners
K223454 · Zhejiang Yinchili Medical Technology Co., Ltd. · Apr 2023
Nightwear Aligners
K221537 · Smylio, Inc. · Apr 2023
Ensmile
K222619 · Ensmile Pvt, Ltd. · Mar 2023
Toothsi, Smilealigners
K223338 · Makeo Healthcare Technologies Private Limited · Feb 2023
Invisalign System, Pre-Formed Attachment System
K222894 · Align Technology, Inc. · Dec 2022
Al Smile Aligner
K222308 · Nanjing Jiahe Dental Technology Co., Ltd. · Dec 2022