Tatum Surgical/IP 4.5 x 6.0mm IP 4.5 x 6.0mm

GUDID 00083208450693

Press Fit Implant 4.5 x 6.0mm x 3mm Well Morse Taper

Suncoast Dental, Inc

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• Primary Device ID: 00083208450693
• NIH Device Record Key: 7497501e-223b-464c-9f4e-63c7e4e69279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical/IP 4.5 x 6.0mm
• Version Model Number: IP 4.5 x 6.0mm
• Catalog Number: IP 4.5 x 6.0mm
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Outer Diameter: 4.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208450693 [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

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

[00083208450693]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-29

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• 00083208455216 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height
• 00083208456213 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height
• 00083208502217 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height