TSI/ERI Abutment Screw AS 4100 TSI

GUDID D785AS4100TSI0

TSI/ERI Abutment Screw 4.0/5.0mm

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D785AS4100TSI0
• NIH Device Record Key: 7b20e602-181d-4248-bab7-ddf464f817f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI/ERI Abutment Screw
• Version Model Number: Abutment Screw for 4.0/5.0mm TSI/ERI
• Catalog Number: AS 4100 TSI
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D785AS4100TSI0 [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

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

[D785AS4100TSI0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-07
• Device Publish Date: 2024-04-29

On-Brand Devices [TSI/ERI Abutment Screw]

• D785AS4100TSI0: TSI/ERI Abutment Screw 4.0/5.0mm
• D785AS3100TSI0: TSI/ERI Abutment Screw 3.25mm