Tatum Surgical/One Piece Crown and Bridge Angled head implant ITO4.0x17CBA

GUDID 00083208340178

One Piece Dental Implant 4.0mm diameter and 17mm in length crown and bridge angled head

Suncoast Dental, Inc

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• Primary Device ID: 00083208340178
• NIH Device Record Key: 8bfb7436-af20-4cfe-bfd1-d5f1467e0e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical/One Piece Crown and Bridge Angled head implant
• Version Model Number: One Piece/4.0 x 17CBA
• Catalog Number: ITO4.0x17CBA
• 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: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com

Device Dimensions

• Length: 17 Millimeter
• Length: 17 Millimeter
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Outer Diameter: 4 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208340178 [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

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

Moist Heat or Steam Sterilization

[00083208340178]

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

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