TSI/ERI/Macro Locator Abutment 8514

GUDID D7858514BOS0

Locator inserts-4 Pack Block Out Spacers

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: D7858514BOS0
• NIH Device Record Key: 88f43c38-5cd5-480a-a202-5e3f37b14712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI/Macro Locator Abutment
• Version Model Number: Locator inserts-4 Pack
• Catalog Number: 8514
• 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	D7858514BOS0 [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

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

Moist Heat or Steam Sterilization

[D7858514BOS0]

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 Locator Abutment]

• D785895560: Locator Abutment 4mm 4mm Diameter 6mm Height
• D785895450: Locator Abutment 4mm 4mm Diameter 5mm height
• D785895340: Locator Abutment 4mm 4mm Diameter 4mm Height
• D785895230: Locator Abutment 4mm 4mm Diameter 3mm Height
• D785895120: Locator Abutment 4mm 4mm Diameter 2mm Height
• D785895070: Locator Abutment 4mm 4mm Diameter .7mm Height
• D7858915ORANGE0: Locator Inserts-4 Pack Extended Range Replacement Male, 2lbs. (Orange)
• D7858548RED0: Locator Inserts-4 Pack Extended Range Replacement Male, 3lbs. (Red)
• D7858547GREEN0: Locator Inserts-4 Pack Extended Range Replacement Male, 4lbs. (Green)
• D7858529BLUE0: Locator Inserts-4 Pack Replacement Male, 1.5lbs. (Blue)
• D7858527PINK0: Locator Inserts-4 Pack Replacement Male, Light Retention, 3lbs. (Pink)
• D7858524CLEAR0: Locator Inserts-4 Pack Replacement Male, 5lbs. (Clear)
• D7858514BOS0: Locator inserts-4 Pack Block Out Spacers
• D785190260: Locator Abutment 5/6mm 5/6mm Diameter 6mm Height
• D785190150: Locator Abutment 5/6mm 5/6mm Diameter 5mm Height
• D785190040: Locator Abutment 5/6mm 5/6mm Diameter 4mm Height
• D785189930: Locator Abutment 5/6mm 5/6mm Diameter 3mm Height
• D785189820: Locator Abutment 5/6mm 5/6mm Diameter 2mm Height
• D785189760: Locator Abutment 3.25mm 3.25mm Diameter 6mm Height
• D785189650: Locator Abutment 3.25mm 3.25mm Diameter 5mm Height
• D785189540: Locator Abutment 3.25mm 3.25mm Diameter 4mm Height
• D785189430: Locator Abutment 3.25mm 3.25mm Diameter 3mm Height
• D785189320: Locator Abutment 3.25mm 3.25mm Diameter 2mm Height
• D785189270: Locator Abutment 3.25mm 3.25mm Diameter .7mm Height