TSI/ERI Locator Abutment 8949

GUDID D78589490

Overdenture Abutment 0mm, 4.0 mm Diameter, 0mm height

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D78589490
• NIH Device Record Key: f7fe208d-0ba1-4772-b64f-96af9707fcf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI Locator Abutment
• Version Model Number: Locator Abutment 0mm
• Catalog Number: 8949
• 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: false
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78589490 [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

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

[D78589490]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-11
• Device Publish Date: 2025-09-03

Devices Manufactured by OCO BIOMEDICAL INC

• D78589490 - TSI/ERI Locator Abutment: 2025-09-11Overdenture Abutment 0mm, 4.0 mm Diameter, 0mm height
• D78589490 - TSI/ERI Locator Abutment: 2025-09-11 Overdenture Abutment 0mm, 4.0 mm Diameter, 0mm height
• D7850330T0 - Osteotomy Former: 2024-12-11 3.3mm Osteotomy Former 3.3mm Diameter For placement of the 3.6mm Engage Implant (Lower)
• D7853610ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 10mm Length
• 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