Tatum Surgical-Integrity Implant 4.0x20mm, Bone Level ITI-B 4.0 x 20mm

GUDID 00083208494000

Integrity Dental Implant 4.0mm in diameter and 20mm in length, bone level

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208494000
• NIH Device Record Key: f15cc74b-d162-4cb1-83e3-2ad078b1ffa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical-Integrity Implant 4.0x20mm, Bone Level
• Version Model Number: ITI-B 4.0x20
• Catalog Number: ITI-B 4.0 x 20mm
• 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: 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
• 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
• 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: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Height: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208494000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

[00083208494000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-22
• Device Publish Date: 2020-08-24

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