Tatum Surgical-Integrity Platform Switching Abutment 5.0, 15° PITI-5.0 (15°) PS+1.5

GUDID 00083208500619

Integrity Platform Switching Abutment for 5mm implant, 15°, 1.5mm larger platform diameter

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208500619
• NIH Device Record Key: 28420b83-a72e-41c0-bb1c-6842c3ee5241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical-Integrity Platform Switching Abutment 5.0, 15°
• Version Model Number: PITI-5.0 (15°) PS+1.5
• Catalog Number: PITI-5.0 (15°) 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

Device Dimensions

• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter
• Angle: 15 degree
• Height: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208500619 [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

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

[00083208500619]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-17
• Device Publish Date: 2019-10-09

Devices Manufactured by Suncoast Dental, Inc

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• 00083208162220 - Tatum EZ Out Periotome E Kit: 2024-08-07 Tatum EZ Out Periotome E Kit - for Atraumatic extraction of roots and teeth - Inc box and 7 periotomes #1,#2, #3, #4, #5, #6, &
• 00083208135002 - DDP Dental Mirror: 2024-02-07 Dental Mirror, reusable
• 00083208136702 - DDP Extraction Forceps: 2024-02-07 Tooth Extraction Forceps 67A
• 00083208452215 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 2.0mm Cuff Height
• 00083208453212 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
• 00083208454219 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
• 00083208455216 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height