Tatum Surgical-Integrity Implant 8.0x11, Bone Level ITI-B 8.0x11

GUDID 00083208498015

Integrity Dental Implant 8.0mm in diameter and 11mm in length, bone level

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208498015
• NIH Device Record Key: ee85a34a-d207-4826-bfe5-7c2ebdd991e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical-Integrity Implant 8.0x11, Bone Level
• Version Model Number: ITI-B 8.0x11
• Catalog Number: ITI-B 8.0x11
• 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: +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
• 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: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter
• Height: 11 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208498015 [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

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

[00083208498015]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-24
• Device Publish Date: 2020-02-14

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• 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