TSI/ERI/Macro Custom Abutment 3.25 TSI CA-HC

GUDID D785325TSICAHC0

TSI/ERI Transmucosal Healing Abutment 3.25mm 3.25mm Diameter

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D785325TSICAHC0
• NIH Device Record Key: 8f518f0a-b2b9-41e2-b0cc-d55288b1c046
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI/Macro Custom Abutment
• Version Model Number: TSI/ERI Transmucosal Healing Abutment 3.25mm
• Catalog Number: 3.25 TSI CA-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	D785325TSICAHC0 [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

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

Moist Heat or Steam Sterilization

[D785325TSICAHC0]

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: 2016-04-08

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

• D7856TSICAHC0: TSI/ERI Transmucosal Healing Abutment 6mm 6mm Diameter
• D785600940: 6mm Bio-Torq Octagon Tip 6mm Diameter
• D7855TSICAHC0: TSI/ERI Transmucosal Healing Abutment 5mm 5mm Diameter
• D7855IPUCLATSI60: TSI/ERI UCLA Impression Pickup 6mm 6mm Diameter
• D7855IPUCLATSI0: TSI/ERI UCLA Impression Pickup 5mm 5mm Diameter
• D785500940: 5mm Bio-Torq Octagon Tip 5mm Diameter
• D7854TSICAHC0: TSI/ERI Transmucosal Healing Abutment 4mm 4mm Diameter
• D7854IPUCLATSI0: TSI/ERI UCLA Impression Pickup 4mm 4mm Diameter
• D7854CATA60: TSI/ERI Transmucosal Abutment 6mm 6mm Diameter
• D7854CATA50: TSI/ERI Transmucosal Abutment 5mm 5mm Diameter
• D7854CATA0: Transmucosal Abutment 4mm 4mm Diameter
• D785400940: 4mm Bio-Torq Octagon Tip 4mm Diameter
• D785325TSICAHC0: TSI/ERI Transmucosal Healing Abutment 3.25mm 3.25mm Diameter
• D785325IPUCLATSI0: TSI/ERI UCLA Impression Pickup 3.25mm 3.25mm Diameter
• D785325CATA0: TSI/ERI Transmucosal Abutment 3.25mm 3.25mm Diameter
• D78532500840: 3.25mm Bio-Torq Octagon Tip 3.25mm Diameter