TSI/ERI/Healing Abutment 4063 TSI HC

GUDID D7854063TSIHC0

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

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D7854063TSIHC0
• NIH Device Record Key: be1079e5-ed7c-41d6-8ef9-0865fb16f056
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI/Healing Abutment
• Version Model Number: TSI/ERI Healing Abutment (3mm Height)
• Catalog Number: 4063 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	D7854063TSIHC0 [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

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

Moist Heat or Steam Sterilization

[D7854063TSIHC0]

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

Devices Manufactured by OCO BIOMEDICAL INC

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• D7853610ENGPLS0 - Two Stage Bone Level Implant: 2024-12-11 3.6mm diameter X 10mm length Engage Plus Bone Level Implant
• D7853612ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6MM Diameter X 12mm Length
• D7853612ENGPLS0 - Two Stage Bone Level Implant: 2024-12-11 3.6mm diameter X 12mm length Bone Level Implant
• D7853614ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 14mm Length
• D7853614ENGPLS0 - Two Stage Bone Level Implant: 2024-12-11 3.6mm diameter X 14mm length Bone Level Implant
• D7853616ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 16mm Length