TatumSurgical/Integrity 2.5mm Abutment RH Screw for 6.0-8.0mm Implants PITI-2.5 AS

GUDID 00083208925009

Integrity 2.5mm Abutment RH Screw for 6.0-8.0mm Implants

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208925009
• NIH Device Record Key: 2772ae2f-eb9f-4aee-8393-15a32f6c5dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Integrity 2.5mm Abutment RH Screw for 6.0-8.0mm Implants
• Version Model Number: 2.5 RH Integrity Abutment Screw
• Catalog Number: PITI-2.5 AS
• 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
• 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
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208925009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM
• 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: 2019-06-10
• Device Publish Date: 2018-08-24

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• 00083208135002 - DDP Dental Mirror: 2024-02-07 Dental Mirror, reusable
• 00083208136702 - DDP Extraction Forceps: 2024-02-07 Tooth Extraction Forceps 67A
• 00083208452215 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 2.0mm Cuff Height
• 00083208453212 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
• 00083208454219 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
• 00083208455216 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height