Blue Sky Bio Computerized Orthodontic Bracket System— 510(k) K182338

Name: FDA 510(k) clearance K182338
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Substantially Equivalent

Blue Sky Bio

FDA 510(k) clearance K182338 for Blue Sky Bio Computerized Orthodontic Bracket System, Substantially Equivalent on 2018-11-09. Applicant: Blue Sky Bio. Device class: 2.

Clearance details

Applicant: Blue Sky Bio
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2018-08-28
Decision date: 2018-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grayslake, IL, US

Download summary PDF View on FDA.gov ↗

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K000633 — SYNTHETIC GLASS BONE GRAFT MATERIAL2000-05-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.