Tatum Surgical/One Piece Crown and Bridge head implant ITO8.0x17CB

GUDID 00083208180170

One Piece Dental Implant 8.0mm diameter and 17mm in length crown and bridge head

Suncoast Dental, Inc

Screw endosteal dental implant, one-piece

• Primary Device ID: 00083208180170
• NIH Device Record Key: 4565c8b2-e780-48f8-98bb-8898584e923c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical/One Piece Crown and Bridge head implant
• Version Model Number: One Piece/8.0x17CB
• Catalog Number: ITO8.0x17CB
• 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@verizon.net

Device Dimensions

• Length: 17 Millimeter
• Length: 17 Millimeter
• Length: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208180170 [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

[00083208180170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-10
• Device Publish Date: 2018-08-28

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