TatumSurgical/Ball Post for Integrity 6.0-8.0, 6.0 x 1.0mm Cuff Height PITI-BP 6.0x1.0mm

GUDID 00083208601088

Ball Post for Integrity 6.0-8.0, 6.0 x 1.0mm Cuff Height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208601088
• NIH Device Record Key: f2860d1e-5d77-49e2-adbc-7575a5f85799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Ball Post for Integrity 6.0-8.0, 6.0 x 1.0mm Cuff Height
• Version Model Number: 6.0 x 1mm Integrity ball post
• Catalog Number: PITI-BP 6.0x1.0mm
• 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

Device Dimensions

• Height: 1 Millimeter
• Height: 1 Millimeter
• Height: 1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208601088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

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

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• 00083208163333 - Tatum EZ-Flex Periotome Kit: 2025-10-07 Tatum EZ-Flex Periotome Kit - for Atraumatic extraction of roots and teeth - Includes box and 8 Flexible Periotomes
• 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