Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5 PITI-3.7-4.5 (0°) PS+1.5

GUDID 00083208134609

Integrity Platform Switching Abutment for 3.7-4.5 implants, 1.5mm larger platform diameter

Suncoast Dental, Inc

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00083208134609
• NIH Device Record Key: d27bf178-a259-45b8-b4c0-31ed5cd1c256
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5
• Version Model Number: PITI-3.7-4.5 (0°) PS+1.5
• Catalog Number: PITI-3.7-4.5 (0°) PS+1.5
• 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: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com

Device Dimensions

• Height: 7 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208134609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

[00083208134609]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-28
• Device Publish Date: 2021-06-18

On-Brand Devices [Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5]

• 00083208345616: Integrity Platform Switching Abutment for 3.7-4.5mm implant, 1.5mm larger platform diameter
• 00083208345630: Integrity Platform Switching Abutment for 3.7-4.5mm implant, 1.5mm larger diameter platform
• 00083208134609: Integrity Platform Switching Abutment for 3.7-4.5 implants, 1.5mm larger platform diameter