Company · US

Blue Sky Bio, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.

21510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DZE	Implant, Endosseous, Root-Form	10
NXC	Aligner, Sequential	3
LYC	Bone Grafting Material, Synthetic	2
NHA	Abutment, Implant, Dental, Endosseous	2
DYW	Bracket, Plastic, Orthodontic	1
EIH	Powder, Porcelain	1
LLZ	System, Image Processing, Radiological	1
OAT	Implant, Endosseous, Orthodontic	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Apr 3, 2024	K232653	Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX Blue Sky Bio, LLC	NXC
Feb 24, 2023	K221845	Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G Blue Sky Bio, LLC	NXC
Jun 30, 2022	K212785	Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments Blue Sky Bio, LLC	DZE
Dec 18, 2020	K202026	Blue Sky Bio CAD-CAM Abutments Blue Sky Bio, LLC	NHA
Dec 17, 2020	K201919	Blue Sky Bio TAD Blue Sky Bio, LLC	OAT
Aug 12, 2019	K190491	Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC	NHA
Nov 9, 2018	K182338	Blue Sky Bio Computerized Orthodontic Bracket System Blue Sky Bio	DYW
Feb 9, 2018	K180107	Blue Sky Bio Aligner Blue Sky Bio, LLC	NXC
Aug 4, 2017	K163251	Life Essence Universal Porcelain System Blue Sky Bio	EIH
Apr 29, 2016	K153064	Blue Sky Bio Zygomatic Implant System Blue Sky Bio, LLC	DZE
Jan 27, 2012	K112875	BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS Blue Sky Bio, LLC	DZE
Dec 22, 2011	K110198	BLUE SKY BIO TCP Blue Sky Bio, LLC	LYC
Apr 19, 2011	K102034	BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC	DZE
Apr 22, 2009	K090607	BLUE SKY BIO PLAN, VERSION .38 Blue Sky Bio, LLC	LLZ
Mar 28, 2008	K073713	BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC	DZE
Mar 29, 2007	K063874	DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC	DZE
May 5, 2006	K060957	MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC	DZE
Sep 2, 2005	K051507	MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC	DZE
Jun 10, 2002	K021833	MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM Blue Sky Bio	DZE
Sep 28, 2001	K010882	BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio	DZE
May 25, 2000	K000633	SYNTHETIC GLASS BONE GRAFT MATERIAL Blue Sky Bio	LYC

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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