TSI OFFSET ABUTMENT SPLINE 4250 TSI L (SPLINE)

GUDID D7854250TSILSP0

4.0mm OFFSET SHIELD ABUTMENT LONG (SPLINE)

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7854250TSILSP0
• NIH Device Record Key: 9a5d8755-6439-4e5a-b42e-70c3ac26935f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI OFFSET ABUTMENT SPLINE
• Version Model Number: 4.0mm OFFSET SHIELD ABUTMENT LONG SPLINE
• Catalog Number: 4250 TSI L (SPLINE)
• 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	D7854250TSILSP0 [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

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

[D7854250TSILSP0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-22
• Device Publish Date: 2024-02-14

On-Brand Devices [TSI OFFSET ABUTMENT SPLINE]

• D7854250TSISSP0: 4.0mm OFFSET SHIELD ABUTMENT SHORT (SPLINE)
• D7854250TSILSP0: 4.0mm OFFSET SHIELD ABUTMENT LONG (SPLINE)
• D7854200TSISP0: 4.0 & 5.0mm TSI HEX INDEXING OFF-SET ABUTMENT (SPLINE)