Cleared Traditional

Blue Sky Bio Computerized Orthodontic Bracket System

K182338 · Blue Sky Bio · Dental
Nov 2018
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K182338 is an FDA 510(k) clearance for the Blue Sky Bio Computerized Orthodontic Bracket System, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Blue Sky Bio (Grayslake, US). The FDA issued a Cleared decision on November 9, 2018, 73 days after receiving the submission on August 28, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K182338 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2018
Decision Date November 09, 2018
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYW — Bracket, Plastic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470

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