Tatum Surgical/One Piece small ball head implant ITO5.0x20SB

GUDID 00083208250200

One Piece Dental Implant 5.0mm diameter and 20mm in length small ball head

Suncoast Dental, Inc

Screw endosteal dental implant, one-piece

• Primary Device ID: 00083208250200
• NIH Device Record Key: 37cb6620-e356-4a6c-8c44-6a827e4aa615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical/One Piece small ball head implant
• Version Model Number: One Piece/5.0x20SB
• Catalog Number: ITO5.0x20SB
• 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

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208250200 [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

[00083208250200]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-20
• Device Publish Date: 2018-07-18

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