Tatum Surgical-Ball Post BP 35.3.S (Hex)

GUDID 00083208350344

Small Ball Post 3.5mm Diameter x 3mm tissue cuff height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208350344
• NIH Device Record Key: 79496150-cc0e-403d-bb33-1f93448f2d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical-Ball Post
• Version Model Number: Small Ball Post 3.5x3mm
• Catalog Number: BP 35.3.S (Hex)
• 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: tatumimplants@verizon.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
• 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

• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208350344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM
• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

[00083208350344]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [Tatum Surgical-Ball Post]

• 00083208450556: Small Ball Post 4.5mm Diameter x 5mm tissue cuff height
• 00083208450532: Large Ball Post 4.5mm Diameter x 5mm tissue cuff height
• 00083208450358: Small Ball Post 4.5mm Diameter x 3mm tissue cuff height
• 00083208450334: Large Ball Post 4.5mm Diameter x 3mm tissue cuff height
• 00083208450150: Small Ball Post 4.5mm Diameter x 1mm tissue cuff height
• 00083208450136: Large Ball Post 4.5mm Diameter x 1mm tissue cuff height
• 00083208400544: Small Ball Post 4.0mm Diameter x 5mm tissue cuff height
• 00083208400537: Large Ball Post 4.0mm Diameter x 5mm tissue cuff height
• 00083208400346: Small Ball Post 4.0mm Diameter x 3mm tissue cuff height
• 00083208400339: Large Ball Post 4.0mm Diameter x 3mm tissue cuff height
• 00083208400148: Small Ball Post 4.0mm Diameter x 1mm tissue cuff height
• 00083208400131: Large Ball Post 4.0mm Diameter x 1mm tissue cuff height
• 00083208350542: Small Ball Post 3.5mm Diameter x 5mm tissue cuff height
• 00083208350535: Large Ball Post 3.5mm Diameter x 5mm tissue cuff height
• 00083208350344: Small Ball Post 3.5mm Diameter x 3mm tissue cuff height
• 00083208350337: Large Ball Post 3.5mm Diameter x 3mm tissue cuff height
• 00083208350146: Small Ball Post 3.5mm Diameter x 1mm tissue cuff height
• 00083208350139: Large Ball Post 3.5mm Diameter x 1mm tissue cuff height