TatumSurgical/Large Ball Post BP 40.1.L (HEX)

GUDID 00083208400100

Large Ball Post 4.0mm Diameter x 1mm tissue cuff height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208400100
• NIH Device Record Key: 1e48ba34-f762-44ee-b4df-2df634e0d7c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Large Ball Post
• Version Model Number: Large Ball Post/4.0mmx1mm
• Catalog Number: BP 40.1.L (HEX)
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208400100 [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: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2015-10-30

On-Brand Devices [TatumSurgical/Large Ball Post]

• 00083208500503: Large Ball Post 5.0mm Diameter x 5mm tissue cuff height
• 00083208500305: Large Ball Post 5.0mm Diameter x 3mm tissue cuff height
• 00083208500107: Large Ball Post 5.0mm Diameter x 1mm tissue cuff height
• 00083208450501: Large Ball Post 4.5mm Diameter x 5mm tissue cuff height
• 00083208450303: Large Ball Post 4.5mm Diameter x 3mm tissue cuff height
• 00083208450105: Large Ball Post 4.5mm Diameter x 1mm tissue cuff height
• 00083208400506: Large Ball Post 4.0mm Diameter x 5mm tissue cuff height
• 00083208400308: Large Ball Post 4.0mm Diameter x 3mm tissue cuff height
• 00083208400100: Large Ball Post 4.0mm Diameter x 1mm tissue cuff height
• 00083208350504: Large Ball Post 3.5mm Diameter x 5mm tissue cuff height
• 00083208350306: Large Ball Post 3.5mm Diameter x 3mm tissue cuff height
• 00083208350108: Large Ball Post 3.5mm Diameter x 1mm tissue cuff height