Tatum Surgical Integrity Analog ITI-OT XFer Screw 2.0

GUDID 00083208920028

Integrity Open Tray Transfer Screw 2.0mm

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208920028
• NIH Device Record Key: 85cc1a76-6df0-488c-8178-8e4888bdadbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical Integrity
• Version Model Number: Analog ITI-OT XFer Screw 2.0
• Catalog Number: Analog ITI-OT XFer Screw 2.0
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(727)536-4880
• Email: tatumimplants@verizon.net
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com

Device Dimensions

• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208920028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous
• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

[00083208920028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [Tatum Surgical Integrity]

• 00083208925023: Integrity Open Tray Transfer Screw 2.5mm
• 00083208920028: Integrity Open Tray Transfer Screw 2.0mm