TatumSurgical/Ball Post for Integrity 5.0, 5.0 x 3.0mm Cuff Height PITI-BP 5.0x3.0mm

GUDID 00083208503085

Ball Post for Integrity 5.0, 5.0 x 3.0mm Cuff Height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208503085
• NIH Device Record Key: c68d5d28-979f-495e-a526-f2325d519c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Ball Post for Integrity 5.0, 5.0 x 3.0mm Cuff Height
• Version Model Number: 5.0 x 3mm Integrity ball post
• Catalog Number: PITI-BP 5.0x3.0mm
• 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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Height: 3 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208503085 [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: 2018-07-27

Devices Manufactured by Suncoast Dental, Inc

• 00083208191121 - Tatum Sinus Instrument Kit: 2024-10-03 Tatum double ended Sinus Instruments, Kit of 10, Inc. Surgical Instrument Tray
• 00083208162220 - Tatum EZ Out Periotome E Kit: 2024-08-07 Tatum EZ Out Periotome E Kit - for Atraumatic extraction of roots and teeth - Inc box and 7 periotomes #1,#2, #3, #4, #5, #6, &
• 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