Tatum Surgical Integrity Abutment PITI-3.7 - 4.5 (15°)

GUDID 00083208915345

Integrity Implant Abutment 3.7 - 4.5mm x 15° angled -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm.

Suncoast Dental, Inc

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• Primary Device ID: 00083208915345
• NIH Device Record Key: 8937bf24-b88a-4f39-b953-4011f1feb20b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical Integrity Abutment
• Version Model Number: Abutment3.7 - 4.5mm x 15° (Straight) Integrity Pos
• Catalog Number: PITI-3.7 - 4.5 (15°)
• 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: 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
• 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
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com

Device Dimensions

• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Height: 7 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208915345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-21
• Device Publish Date: 2020-11-17

On-Brand Devices [Tatum Surgical Integrity Abutment ]

• 00083208915680: Integrity Implant Abutment 6.0 - 8.0mm x 15° (Angle) -7mm Height. To fit Integrity Implants dia
• 00083208915345: Integrity Implant Abutment 3.7 - 4.5mm x 15° angled -7mm Height. To fit Integrity Implants diam
• 00083208906787: Integrity Implant Abutment 6.0 - 8.0mm x 0° (Straight) -7mm Height. To fit Integrity Implants d
• 00083208903458: Integrity Implant Abutment 3.7 - 4.5mm x 0° (Straight) -7mm Height. To fit Integrity Implants d