Tatum Surgical/One Piece Crown and Bridge Angled head implant ITO3.5x23CBA

GUDID 00083208335235

One Piece Dental Implant 3.5mm diameter and 23mm in length crown and bridge angled head

Suncoast Dental, Inc

Screw endosteal dental implant, one-piece

• Primary Device ID: 00083208335235
• NIH Device Record Key: ac4568be-bf1a-420f-bd0b-3dc0e276ff76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical/One Piece Crown and Bridge Angled head implant
• Version Model Number: One Piece/3.5 x 23 CBA
• Catalog Number: ITO3.5x23CBA
• 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: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208335235 [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

[00083208335235]

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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