5mm Natural Contour Abutment 5350 TSI/ERI

GUDID D7855350TSIERI0

5mm Diameter Natural Contour Abutment

OCO BIOMEDICAL INC

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• Primary Device ID: D7855350TSIERI0
• NIH Device Record Key: 6b774ca7-229b-4d57-a81c-52c2323da181
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5mm Natural Contour Abutment
• Version Model Number: Natural Contour Abutment
• Catalog Number: 5350 TSI/ERI
• 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	D7855350TSIERI0 [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

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

Moist Heat or Steam Sterilization

[D7855350TSIERI0]

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: 2016-03-22

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• D78550SB0 - SCAN BODY: 2024-07-04 TSI/ERI 5.0MM SCAN BODY
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• D78562020 - Osteotome Tray: 2024-07-04 Osteotome Tray
• D78562050 - Engage Compact Kit: 2024-07-04 Engage Compact Kit Case