510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K232653Substantially Equivalent

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX

Blue Sky Bio, LLC, Libertyville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232653 is the FDA 510(k) clearance record for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX, a class II device, cleared for Blue Sky Bio, LLC on under FDA product code NXC (Aligner, Sequential). FDA's definition for product code NXC reads: "The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion". FDA records list 21 510(k) clearances for Blue Sky Bio, LLC, from to . As of , FDA records show no recalls naming K232653.

Clearance record

Decision date
Received
(216 days to decision)
Product code
NXC Aligner, Sequential
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Blue Sky Bio, LLC 800 Liberty Dr., Libertyville IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXC

Trailing 12 months
6 clearances under product code NXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NXC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260