3.25mm Offset Shielded 15 Degree Abutment 3250 TSI S

GUDID D7853250TSIS0

3.25mm Diameter Offset Shielded 15 Degree Abutment Short

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D7853250TSIS0
• NIH Device Record Key: 48a4cb0f-6d91-4d22-9c14-3a297d619259
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.25mm Offset Shielded 15 Degree Abutment
• Version Model Number: Offset Shielded 15 Degree Abutment
• Catalog Number: 3250 TSI S
• 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	D7853250TSIS0 [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

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

Moist Heat or Steam Sterilization

[D7853250TSIS0]

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: 2016-03-22

On-Brand Devices [3.25mm Offset Shielded 15 Degree Abutment]

• D7853250TSIS0: 3.25mm Diameter Offset Shielded 15 Degree Abutment Short
• D7853250TSIL0: 3.25mm Diameter Offset Shielded 15 Degree Abutment Long