BLT OS Abutment Screw

GUDID 08809486111062

EBI Inc.

Dental implant system

• Primary Device ID: 08809486111062
• NIH Device Record Key: 50118e89-9519-4190-890c-f7cf45d8d913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLT OS Abutment Screw
• Version Model Number: ONOASR
• Company DUNS: 689515003
• Company Name: EBI Inc.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809486111062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190837

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

[08809486111062]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

Devices Manufactured by EBI Inc.

• 08809476186407 - BLT OS Analog: 2024-12-20
• 08809486111062 - BLT OS Abutment Screw: 2024-12-20
• 08809486111062 - BLT OS Abutment Screw: 2024-12-20
• 08809890906483 - BLT OS Impression Coping: 2024-12-20
• 08809475970410 - CCM UCLA Abutment (for Precision) [OCT]: 2019-11-08
• 08809475970427 - CCM UCLA Abutment (for Precision) [Non-Octa]: 2019-11-08
• 08809475970434 - CCM UCLA Abutment (for BESTic) [OCT]: 2019-11-08
• 08809475970441 - CCM UCLA Abutment (for BESTic) [Non-Octa]: 2019-11-08
• 08809475970670 - Precision Gold UCLA Abutment: 2019-11-08