TSI/ERI/Macro Healing Abutment 4065 TSI HC

GUDID D7854065TSIHC0

4mm TSI/ERI Healing Abutment (3mm Height) 4mm Diameter

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D7854065TSIHC0
• NIH Device Record Key: 8170aa49-6f40-4b01-b509-b4ae091754a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI/Macro Healing Abutment
• Version Model Number: TSI/ERI Healing Abutment (3mm Height)
• Catalog Number: 4065 TSI HC
• 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	D7854065TSIHC0 [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

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

Moist Heat or Steam Sterilization

[D7854065TSIHC0]

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: 2017-02-12

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

• D7855064TSIHC0: 5mm TSI/ERI Healing Abutment (4mm Height) 5mm Diameter
• D78550646TSIHC0: 6mm TSI/ERI Healing Abutment (4mm Height) 6mm Diameter
• D7855063TSIHC0: 5mm TSI/ERI Healing Abutment (3mm Height) 5mm Diameter
• D78550636TSIHC0: 6mm TSI/ERI Healing Abutment (3mm Height) 6mm Diameter
• D7855062TSIHC0: 5mm TSI/ERI Healing Abutment (2mm Height) 5mm Diameter
• D78550626TSIHC0: 6mm TSI/ERI Healing Abutment (2mm Height) 6mm Diameter
• D7854065TSIHC0: 4mm TSI/ERI Healing Abutment (3mm Height) 4mm Diameter
• D7854064TSIHC0: 4mm TSI/ERI Healing Abutment (4mm Height) 4mm Diameter
• D7854062TSIHC0: 4mm TSI/ERI Healing Abutment (2mm Height) 4mm Diameter
• D7853065TSIHC0: 3.25mm TSI/ERI Healing Abutment (3mm Height) 3.25mm Diameter
• D7853064TSIHC0: 3.25mm TSI/ERI Healing Abutment (4mm Height) 3.25mm Diameter
• D7853063TSIHC0: 3.25mm TSI/ERI Healing Abutment (3mm Height) 3.25mm Diameter
• D7853062TSIHC0: 3.25mm TSI/ERI Healing Abutment (2mm Height) 3.25mm Diameter