510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182338Substantially Equivalent

Blue Sky Bio Computerized Orthodontic Bracket System

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

K182338 is the FDA 510(k) clearance record for Blue Sky Bio Computerized Orthodontic Bracket System, a class II device, cleared for Blue Sky Bio on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list 21 510(k) clearances for Blue Sky Bio, from to . As of , FDA records show no recalls naming K182338.

Clearance record

Decision date
Received
(73 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Blue Sky Bio 888 E Belvedere Rd. Suite 212, Grayslake IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DYW

Trailing 12 months
1 clearance under product code DYW 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 DYW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260