TSI OFFSET ABUTMENT SPLINE 4200 TSI (SPLINE)

GUDID D7854200TSISP0

4.0 & 5.0mm TSI HEX INDEXING OFF-SET ABUTMENT (SPLINE)

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7854200TSISP0
• NIH Device Record Key: 93ba9353-05f8-415d-b22c-808d68cb8789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI OFFSET ABUTMENT SPLINE
• Version Model Number: 4.0 & 5.0mm TSI HEX INDEXING OFF-SET ABUTMENT SPLI
• Catalog Number: 4200 TSI (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	D7854200TSISP0 [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

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

Moist Heat or Steam Sterilization

[D7854200TSISP0]

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)