FDA.report

Blue Sky Bio, LLC.

Primary DI
00815131027013
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
Z9822B1
Published
2018-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815131027013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815131027013008151310270138151310270130815131027013

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Regulatory Flags

DUNS number
618960848
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810060227046Blue Sky Bio, LLC.BDSJH2026-02-10
00810060226933Blue Sky Bio, LLC.HHS3565502025-10-16
00810060226940Blue Sky Bio, LLC.HHS3565702025-10-16
00810060226834Blue Sky Bio, LLC.GDT-USP2025-07-25
00810060226841Blue Sky Bio, LLC.GDT-UMP2025-07-25
00810060226858Blue Sky Bio, LLC.GDT-ULP2025-07-25
00810060226865Blue Sky Bio, LLC.GDT-LSP2025-07-25
00810060226872Blue Sky Bio, LLC.GDT-LMP2025-07-25
00810060226889Blue Sky Bio, LLC.GDT-LLP2025-07-25
00810060226629Blue Sky Bio, LLC. HSSQN38302025-07-23
00810060226636Blue Sky Bio, LLC.HSSQN38502025-07-23
00810060226643Blue Sky Bio, LLC.HSSQN38702025-07-23
00810060226650Blue Sky Bio, LLC.HSSQN48302025-07-23
00810060226667Blue Sky Bio, LLC.HSSQN48502025-07-23
00810060226674Blue Sky Bio, LLC.HSSQN48702025-07-23
00810060226681Blue Sky Bio, LLC.HSSQN65302025-07-23
00810060226698Blue Sky Bio, LLC.HSSQN65502025-07-23
00810060226704Blue Sky Bio, LLC.HSSQN65702025-07-23
00810060226711Blue Sky Bio, LLC.HSSQR38302025-07-23
00810060226728Blue Sky Bio, LLC.HSSQR38502025-07-23

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