BLUE SKY BIO LLC

Address:800 Liberty Drive,Libertyville,IL,60048,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Abutment, Implant, Dental, Endosseous (NHA) (7) Pin, Retentive And Splinting, And Accessory Instruments (EBL) (3)

Premarket Exempt

No Yes

Clear

Blue Sky Bio, LLC. - 00810060220009 Catalog Number :

Device Description : Drill Profile H 4.1mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220016 Catalog Number :

Device Description : Drill Profile H 4.7mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220023 Catalog Number :

Device Description : Drill Profile H 5.7mm

Device Class : 1

Duns Number: 618960848

Premarket Exempt : Yes

Product Code : EBL

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220030 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 17 degree, 1.5mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220047 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 17 degree, 2.0mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220054 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 17 degree, 3.0mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220061 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 30 degree, 1.5mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220078 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 17 degree, 5.0mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220085 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 30 degree, 2.0mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blue Sky Bio, LLC. - 00810060220092 Catalog Number :

Device Description : BIO MAX Flat Snap Abutment NP 30 degree, 3.0mm Collar

Device Class : 2

Duns Number: 618960848

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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