Medical Device Manufacturer · US , Grayslake , IL

Blue Sky Bio, LLC - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2005

Recent clearances: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX, Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G, Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments

16
Total
16
Cleared
0
Denied

FDA 510(k) Regulatory Record - Blue Sky Bio, LLC Dental ✕

15 devices
1-12 of 15
Cleared Apr 03, 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · NXC
Dental · 216d
Cleared Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845 · NXC
Dental · 245d
Cleared Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue...
K212785 · DZE
Dental · 302d
Cleared Dec 18, 2020
Blue Sky Bio CAD-CAM Abutments
K202026 · NHA
Dental · 149d
Cleared Dec 17, 2020
Blue Sky Bio TAD
K201919 · OAT
Dental · 160d
Cleared Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
K190491 · NHA
Dental · 165d
Cleared Feb 09, 2018
Blue Sky Bio Aligner
K180107 · NXC
Dental · 24d
Cleared Apr 29, 2016
Blue Sky Bio Zygomatic Implant System
K153064 · DZE
Dental · 190d
Cleared Jan 27, 2012
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
K112875 · DZE
Dental · 119d
Cleared Dec 22, 2011
BLUE SKY BIO TCP
K110198 · LYC
Dental · 332d
Cleared Apr 19, 2011
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K102034 · DZE
Dental · 274d
Cleared Mar 28, 2008
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K073713 · DZE
Dental · 88d
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