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Data / Medical devices / United States / Blue Sky Bio, LLC

Blue Sky Bio, LLC: FDA-registered device maker in Libertyville, IL, United States, 15 510(k) clearances

Blue Sky Bio, LLC is registered with the FDA (registration 3003402534) in Libertyville, IL, United States. It lists 12 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 24, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Blue Sky Bio, LLC
FDA registration number
3003402534
Address
800 Liberty Drive, Libertyville, IL, United States, 60048
Owner or operator
BLUE SKY BIO, LLC (9040515)
Roles
Specification developer
First device listed
October 13, 2006
Registered through
2026
Brand names listed
Blue Sky Bio, Blue Sky Bio CAD-CAM Abutments, Blue Sky Bio Dental Implant Accessories, Blue Sky Bio Dental Implant System, Blue Sky Bio Dental Implant System - Bio / Conus, Blue Sky Bio Dental Implant System - Double Hex 3 Platform, Blue Sky Bio Dental Implant System - Internal Hex, Blue Sky Bio Dental Implant System - Internal Octagon Taper and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Specification developeraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Specification developeraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Specification developeraccessdata.fda.gov
Aligner, SequentialNXC2Specification developeraccessdata.fda.gov
Bracket, Plastic, OrthodonticDYW2Specification developeraccessdata.fda.gov
Implant, Endosseous, OrthodonticOAT2Specification developeraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Specification developeraccessdata.fda.gov
Orthodontic SoftwarePNN2Specification developeraccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Specification developeraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Specification developeraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 24, 2023K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GNXCSubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
June 30, 2022K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
December 18, 2020K202026Blue Sky Bio CAD-CAM AbutmentsNHASubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
December 17, 2020K201919Blue Sky Bio TADOATSubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
August 12, 2019K190491Blue Sky Bio Zygomatic Implant SystemNHASubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
November 9, 2018K182338Blue Sky Bio Computerized Orthodontic Bracket SystemDYWSubstantially EquivalentBlue Sky Bioaccessdata.fda.gov
February 9, 2018K180107Blue Sky Bio AlignerNXCSubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
April 29, 2016K153064Blue Sky Bio Zygomatic Implant SystemDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
January 27, 2012K112875BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMSDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
April 19, 2011K102034BLUE SKY BIO DENTAL IMPLANT SYSTEMDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
April 22, 2009K090607BLUE SKY BIO PLAN, VERSION .38LLZSubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
March 28, 2008K073713BLUE SKY BIO DENTAL IMPLANT SYSTEMDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
May 5, 2006K060957MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
September 2, 2005K051507MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMDZESubstantially EquivalentBlue Sky Bio, LLCaccessdata.fda.gov
September 28, 2001K010882BLUE SKY BIO DENTAL IMPLANT SYSTEMDZESubstantially EquivalentBlue Sky Bioaccessdata.fda.gov

Compare with other makers

Updated February 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.