TatumSurgical/Small Ball Post BP 35.1.S

GUDID 00083208350115

Small Ball Post 3.5mm Diameter x 1mm tissue cuff height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208350115
• NIH Device Record Key: 99d9b7fd-e0aa-4d56-b13d-35d01e683695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Small Ball Post
• Version Model Number: Small Ball Post/3.5mmx1mm
• Catalog Number: BP 35.1.S
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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@verivon.net

Device Dimensions

• Height: 1 Millimeter
• Height: 1 Millimeter
• Height: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208350115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-21
• Device Publish Date: 2015-10-30

On-Brand Devices [TatumSurgical/Small Ball Post]

• 00083208500510: Small Ball Post 5.0mm Diameter x 5mm tissue cuff height
• 00083208500312: Small Ball Post 5.0mm Diameter x 3mm tissue cuff height
• 00083208500114: Small Ball Post 5.0mm Diameter x 1mm tissue cuff height
• 00083208451010: Small Ball Post 4.5mm Diameter x 1mm tissue cuff height
• 00083208450518: Small Ball Post 4.5mm Diameter x 5mm tissue cuff height
• 00083208450310: Small Ball Post 4.5mm Diameter x 3mm tissue cuff height
• 00083208400513: Small Ball Post 4.0mm Diameter x 5mm tissue cuff height
• 00083208400315: Small Ball Post 4.0mm Diameter x 3mm tissue cuff height
• 00083208400117: Small Ball Post 4.0mm Diameter x 1mm tissue cuff height
• 00083208350511: Small Ball Post 3.5mm Diameter x 5mm tissue cuff height
• 00083208350313: Small Ball Post 3.5mm Diameter x 3mm tissue cuff height
• 00083208350115: Small Ball Post 3.5mm Diameter x 1mm tissue cuff height