FDA.reportPublic FDA data

Blue Sky Bio, LLC.

Primary DI
00810060227008
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
HHS456570
Device description
Bio Internal Hex Healing Abutment 6.5mm Dia x 7.0mm, 4.5mm Platform, Indexed
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060957000MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2006-05-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060227008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060227008008100602270088100602270080810060227008

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
618960848
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070202999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28