TatumSurgical/D Implant ID4S 4.5x16

GUDID 00083208610165

D4S Fin Implant 4.5mm neck diameter, 10.0mm fin width and 16mm in length

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece Blade endosteal dental implant, two-piece

• Primary Device ID: 00083208610165
• NIH Device Record Key: 4dea1c77-1fb5-49f0-9132-e4f4c6f8a75d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/D Implant
• Version Model Number: D4S - Fin/4.5x10.0x16
• Catalog Number: ID4S 4.5x16
• 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
• Phone: +1(727)536-4880
• Email: tatumimplants@verivon.net

Device Dimensions

• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Length: 16 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208610165 [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

[00083208610165]

Moist Heat or Steam Sterilization

[00083208610165]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-30

On-Brand Devices [TatumSurgical/D Implant]

• 00083208675201: D3 Fin Implant 4.5mm neck diameter, 7.5mm fin width and 20mm in length
• 00083208675164: D3S Fin Implant 4.5mm neck diameter, 7.5mm fin width and 16mm in length
• 00083208645204: D2 Fin Implant 4.5mm neck diameter, 4.5mm fin width and 20mm in length
• 00083208645167: D2S Fin Implant 4.5mm neck diameter, 4.5mm fin width and 16mm in length
• 00083208640209: D1 Fin Implant 4.0mm neck diameter, 4.0mm fin width and 20mm in length
• 00083208640162: D1S Fin Implant 4.0mm neck diameter, 4.0mm fin width and 16mm in length
• 00083208610202: D4 Fin Implant 4.5mm neck diameter, 10.0mm fin width and 20mm in length
• 00083208610165: D4S Fin Implant 4.5mm neck diameter, 10.0mm fin width and 16mm in length