3.25mm O-Ball Abutment 3.25 OB 0TSI

GUDID D785325OB0TSI0

3.25mm Fixed Solid O-Ball Abutment 0mm Height For 3.25mm TSI/ERI Implants

OCO BIOMEDICAL INC

Dental implant system Dental implant system Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D785325OB0TSI0
• NIH Device Record Key: 1cd486b2-edcf-42b2-b594-31614ea0a2bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.25mm O-Ball Abutment
• Version Model Number: TSI/ERI O-Ball Abutment
• Catalog Number: 3.25 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	D785325OB0TSI0 [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

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

Moist Heat or Steam Sterilization

[D785325OB0TSI0]

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 [3.25mm O-Ball Abutment]

• D785325OB4TSI0: 3.25mm Fixed Solid O-Ball Abutment 4mm Height For 3.25mm TSI/ERI Implants
• D785325OB3TSI0: 3.25mm Fixed Solid O-Ball Abutment 3mm Height For 3.25mm TSI/ERI Implants
• D785325OB2TSI0: 3.25mm Fixed Solid O-Ball Abutment 2mm Height For 3,25mm TSI/ERI Implants
• D785325OB0TSI0: 3.25mm Fixed Solid O-Ball Abutment 0mm Height For 3.25mm TSI/ERI Implants