FDA.reportPublic FDA data

Blue Sky Bio, LLC.

Primary DI
00810060226667
Brand
Blue Sky Bio, LLC.
Company
BLUE SKY BIO LLC
Model
HSSQN4850
Device description
BIO Quattro Healing Abutment 4.8mm x 5.0mm, Narrow Indexed
Published
2025-07-23
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102034000BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2011-04-19DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060226667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060226667008100602266678100602266670810060226667

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
04260516877992SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878005SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878012SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878029SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878036SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878043SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878050SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878067SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878074SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878081SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878098SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878104SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878111SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878128SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878135SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878142SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878159SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878166SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878173SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878180SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04099797001099CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001105CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001112CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001129CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001136CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001143CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001150CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001167CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001174CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001181CONELOG® Healing capALTATEC GmbHNHA2026-08-17