FDA.reportPublic FDA data

Blue Sky Bio, LLC.

Primary DI
00810060226063
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
4.13
Catalog number
BSP
Device description
Blue Sky Plan Software
Published
2024-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYWBracket, Plastic, Orthodontic
LLZSystem, Image Processing, Radiological
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
NXCAligner, Sequential
PNNOrthodontic Software
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2
LLZSystem, Image Processing, RadiologicalRadiology2
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2
NXCAligner, SequentialDental2
PNNOrthodontic SoftwareDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060226063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060226063008100602260638100602260630810060226063

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Regulatory Flags#

DUNS number
618960848
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060227060Blue Sky Bio, LLCIJHTP30102026-04-22
00810060227077Blue Sky Bio, LLCIJHTP30112026-04-22
00810060227084Blue Sky Bio, LLCIJHTP30132026-04-22
00810060227091Blue Sky Bio, LLCIJHTP30162026-04-22
00810060227107Blue Sky Bio, LLCIJHTP35082026-04-22
00810060227114Blue Sky Bio, LLCIJHTP35102026-04-22
00810060227121Blue Sky Bio, LLCIJHTP35112026-04-22
00810060227138Blue Sky Bio, LLCIJHTP35132026-04-22
00810060227145Blue Sky Bio, LLCIJHTP35162026-04-22
00810060227152Blue Sky Bio, LLCIJHTP43062026-04-22
00810060227169Blue Sky Bio, LLCIJHTP43082026-04-22
00810060227176Blue Sky Bio, LLCIJHTP43102026-04-22
00810060227183Blue Sky Bio, LLCIJHTP43112026-04-22
00810060227190Blue Sky Bio, LLCIJHTP43132026-04-22
00810060227206Blue Sky Bio, LLCIJHTP43162026-04-22
00810060227213Blue Sky Bio, LLCIJHTP50062026-04-22
00810060227220Blue Sky Bio, LLCIJHTP50082026-04-22
00810060227237Blue Sky Bio, LLCIJHTP50102026-04-22
00810060227244Blue Sky Bio, LLCIJHTP50112026-04-22
00810060227251Blue Sky Bio, LLCIJHTP50132026-04-22

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06942799000837Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000844Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000851Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
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D82948002001000101Premium LineEC Certification Service GmbHDYW2026-07-30
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D82948002701000051Premium LineEC Certification Service GmbHDYW2026-07-30