Blue Sky Bio is one of 16108 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Blue Sky Bio - FDA 510(k) Cleared Devices
Recent clearances: Blue Sky Bio Computerized Orthodontic Bracket System, Life Essence Universal Porcelain System, MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
5
Total
5
Cleared
0
Denied
Blue Sky Bio has 5 FDA 510(k) cleared medical devices. Based in Irvine, US.
Historical record: 5 cleared submissions from 2000 to 2018. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Blue Sky Bio Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Blackwell Device Consulting and Third Party Review Group, LLC.
FDA 510(k) Regulatory Record - Blue Sky Bio
5 devices
Cleared
Nov 09, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
Dental
73d
Cleared
Aug 04, 2017
Life Essence Universal Porcelain System
Dental
259d
Cleared
Jun 10, 2002
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
Dental
6d
Cleared
Sep 28, 2001
BLUE SKY BIO DENTAL IMPLANT SYSTEM
Dental
189d
Cleared
May 25, 2000
SYNTHETIC GLASS BONE GRAFT MATERIAL
Dental
90d