Blue Sky Bio, LLC

GUDID 00815131022070

BLUE SKY BIO LLC

Screw endosteal dental implant, two-piece

• Primary Device ID: 00815131022070
• NIH Device Record Key: a62ecd4b-e26d-45f1-ab33-00cd8df07a06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blue Sky Bio, LLC
• Version Model Number: ITT4316
• Company DUNS: 618960848
• Company Name: BLUE SKY BIO LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815131022070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060957

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00815131022070]

Radiation Sterilization

[00815131022070]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-18
• Device Publish Date: 2015-10-24

Devices Manufactured by BLUE SKY BIO LLC

• 00810060226353 - Blue Sky Bio, LLC.: 2025-03-11 Screw, Multiunit Angled Base Abutment
• 00810060226360 - Blue Sky Bio, LLC.: 2025-03-11 Multiunit Base Abutment, Angled
• 00810060226377 - Blue Sky Bio, LLC.: 2025-03-11 Bio | Max PEEK Temporary Abutment NP
• 00810060226346 - Blue Sky Bio, LLC.: 2025-02-28 Blue Sky Plan Software
• 00810060226292 - Blue Sky Bio, LLC.: 2025-02-03 BIO | Conus 12 Implant System Surgical Instrument Box
• 00810060226308 - Blue Sky Bio, LLC.: 2025-02-03 BIO | Internal Hex System Surgical Instrument Box
• 00810060226315 - Blue Sky Bio, LLC.: 2025-02-03 BIO | Max Implant System Surgical Instrument Box
• 00810060226322 - Blue Sky Bio, LLC.: 2025-02-03 BIO | One Stage Implant System Surgical Instrument Box