TSI/ERI/Macro Abutment 3200 TSI

GUDID D7853200TSI0

Offset Pedestal 15 Degree Abutment 3.25mm Diameter

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D7853200TSI0
• NIH Device Record Key: 086425de-5d66-4dd3-bb55-3291fa0437ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI/Macro Abutment
• Version Model Number: Offset Pedestal 15 Degree Abutment
• Catalog Number: 3200 TSI
• 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	D7853200TSI0 [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

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

Moist Heat or Steam Sterilization

[D7853200TSI0]

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: 2016-04-07

On-Brand Devices [TSI/ERI/Macro Abutment]

• D7854200TSI0: Offset Pedestal 15 Degree Abutment 4mm Diameter
• D78542006TSI0: Offset Pedestal 15 Degree Abutment 6mm Diameter
• D78542005TSI0: Offset Pedestal 15 Degree Abutment 5mm Diameter
• D7853200TSI0: Offset Pedestal 15 Degree Abutment 3.25mm Diameter