Tatum Surgical/One Piece small ball head implant ITO8.0x11SB

GUDID 00083208280115

One Piece Dental Implant 8.0mm diameter and 11mm in length small ball head

Suncoast Dental, Inc

Screw endosteal dental implant, one-piece

• Primary Device ID: 00083208280115
• NIH Device Record Key: e42ba3fd-77a8-4a6d-8ac6-49d087e8aded
• Commercial Distribution Discontinuation: 2019-06-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tatum Surgical/One Piece small ball head implant
• Version Model Number: One Piece/8.0x11SB
• Catalog Number: ITO8.0x11SB
• 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: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208280115 [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

[00083208280115]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-12
• Device Publish Date: 2018-07-18

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