TatumSurgical/Tapered Implant IT4.5x11

GUDID 00083208045110

Tapered Dental Implant 4.5mm in diameter and 11mm in Length

Suncoast Dental, Inc

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• Primary Device ID: 00083208045110
• NIH Device Record Key: 2be59bc6-8eae-4981-9da2-a7674033e3f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Tapered Implant
• Version Model Number: Tapered/4.5x11
• Catalog Number: IT4.5x11
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

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

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 11 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208045110 [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

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

[00083208045110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-30

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