FDA.report

Blue Sky Bio, LLC

Primary DI
00810060222256
Brand
Blue Sky Bio, LLC
Company
BLUE SKY BIO LLC
Model
MOW5500
Device description
BIO | One Stage Implant Impression Transfer Wide
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EHYTray, Impression, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810060222256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060222256008100602222568100602222560810060222256

GMDN Terms

TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

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

Other Devices From This Company

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00810060227046Blue Sky Bio, LLC.BDSJH2026-02-10
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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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