Tatum Surgical-Integrity Platform Switching Abutment 3.7-4.5 PITI-3.7-4.5 (30°) PS+1.5

GUDID 00083208345630

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

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208345630
• NIH Device Record Key: b16810d2-19e0-4292-bc5f-9ea8706003a3
• 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 (30°) PS+1.5
• Catalog Number: PITI-3.7-4.5 (30°) 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: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net
• Phone: 727-536-4880
• Email: tatumimplants@verizon.net

Device Dimensions

• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter
• Angle: 30 degree
• Height: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208345630 [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

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

[00083208345630]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-06
• Device Publish Date: 2019-04-26

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