TSI/ERI/Macro Custom Abutment 0084

GUDID D78532500840

3.25mm Bio-Torq Octagon Tip 3.25mm Diameter

OCO BIOMEDICAL INC

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: D78532500840
• NIH Device Record Key: c5b67b6d-3fdb-4e19-a804-897fc667fe93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI/Macro Custom Abutment
• Version Model Number: 3.25mm Bio-Torq Octagon Tip
• Catalog Number: 0084
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78532500840 [Primary]

FDA Product Code

• EIL: Gauge, Depth, Instrument, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

Moist Heat or Steam Sterilization

[D78532500840]

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: 2016-04-21

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

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• 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