4.0/5.0/6.0mm O-Ball Abutment 4 OB 0TSI

GUDID D7854OB0TSI0

4.0/5.0/6.0mm Fixed Solid O-Ball Abutment 0mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D7854OB0TSI0
• NIH Device Record Key: 1b27605f-bdc0-45dd-95ed-9944b9b1ff56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.0/5.0/6.0mm O-Ball Abutment
• Version Model Number: TSI/ERI/Macro O-Ball Abutment
• Catalog Number: 4 OB 0TSI
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL 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: true
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	D7854OB0TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

[D7854OB0TSI0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-21

On-Brand Devices [4.0/5.0/6.0mm O-Ball Abutment]

• D7854OB4TSI0: 4.0/5.0/6.0mm Fixed Solid O-Ball Abutment 4mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants
• D7854OB3TSI0: 4.0/5.0/6.0mm Fixed Solid O-Ball Abutment 3mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants
• D7854OB2TSI0: 4.0/5.0/6.0 Fixed Solid O-Ball Abutment 2mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants
• D7854OB0TSI0: 4.0/5.0/6.0mm Fixed Solid O-Ball Abutment 0mm Height For 4.0/5.0/6.0mm TSI/ERI/Macro Implants