TOP SYSTEM

GUDID 08800041054305

Surgident Co.,Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08800041054305
• NIH Device Record Key: 0ffad327-e87e-451b-9334-992664d9e49c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOP SYSTEM
• Version Model Number: SD-TOP
• Company DUNS: 689846448
• Company Name: Surgident Co.,Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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
GS1	08800041054305 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

[08800041054305]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-19
• Device Publish Date: 2023-10-11

Devices Manufactured by Surgident Co.,Ltd.

• 08800041065691 - Easy Bone Expander Kit: 2023-11-02
• 08800041065714 - P.R.P MEMBRANE KIT: 2023-11-02
• 08800041065721 - POWERTOME KIT: 2023-11-02
• 08800041065738 - Implant Removal Kit Gen II: 2023-11-02
• 08800041065745 - Screw Fixation Kit: 2023-11-02
• 08800041065752 - Drill Stop Kit: 2023-11-02
• 08800041065769 - Shatkin F.I.R.S.T Sinus Lift Kit: 2023-11-02
• 08800041065776 - Contra Torque: 2023-11-02