FDA.reportPublic FDA data

BLUE SKY BIO, LLC

Matched from indexed company URL: Blue Sky Bio, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30034025343003402534BLUE SKY BIO, LLC1Y2026-01-01800 Liberty Drive Libertyville IL US 60048

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
189961310783298K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GNXC2023-02-24
189961314391507K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsDZE2022-06-30
189962019269063K202026Blue Sky Bio CAD-CAM AbutmentsNHA2020-12-18
189961548771319K201919Blue Sky Bio TADOAT2020-12-17
189961919528158K190491Blue Sky Bio Zygomatic Implant SystemNHA2019-08-12
189961077460226K182338Blue Sky Bio Computerized Orthodontic Bracket SystemDYW2018-11-09
189961634233053K180107Blue Sky Bio AlignerNXC2018-02-09
189961683303405K163251Life Essence Universal Porcelain SystemEIH2017-08-04
189961934394222K153064Blue Sky Bio Zygomatic Implant SystemDZE2016-04-29
189961923409673K112875BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMSDZE2012-01-27
189961451870691K102034BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2011-04-19
189961195757214K090607BLUE SKY BIO PLAN, VERSION .38LLZ2009-04-22
189961838634362K073713BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2008-03-28
189961565236957K060957MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2006-05-05
189961421191014K051507MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2005-09-02
189961897444058K010882BLUE SKY BIO DENTAL IMPLANT SYSTEMDZE2001-09-28
189961058787206
189961492511833
189961506499651
189961786074907
189961842948141

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE82022-06-30
NXC22023-02-24
NHA22020-12-18
OAT12020-12-17
DYW12018-11-09
EIH12017-08-04
LLZ12009-04-22

PMN#

GUDID#

200 records. Showing 1-40. Next