TatumSurgical/Abutment (Integrity Post) PITI-80.00

GUDID 00083208980008

Integrity Implant Abutment 8.0mm x 0 degree -7mm Height

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208980008
• NIH Device Record Key: a57e02b5-ed3e-481a-b813-ab4179c135c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Abutment (Integrity Post)
• Version Model Number: Abutment/8.0mm x 0 degree Straight Integrity Post
• Catalog Number: PITI-80.00
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208980008 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-30

On-Brand Devices [TatumSurgical/Abutment (Integrity Post)]

• 00083208980305: Integrity Implant Abutment 8.0mm x 30 degree -7mm Height
• 00083208980152: Integrity Implant Abutment 8.0mm x 15 degree -7mm Height
• 00083208980008: Integrity Implant Abutment 8.0mm x 0 degree -7mm Height
• 00083208970306: Integrity Implant Abutment 7.0mm x 30 degree -7mm Height
• 00083208970153: Integrity Implant Abutment 7.0mm x 15 degree -7mm Height
• 00083208970009: Integrity Implant Abutment 7.0mm x 0 degree -7mm Height
• 00083208960307: Integrity Implant Abutment 6.0mm x 30 degree -7mm Height
• 00083208960154: Integrity Implant Abutment 6.0-8.0mm x 15 degree -7mm Height
• 00083208960000: Integrity Implant Abutment 6.0mm x 0 degree -7mm Height
• 00083208950308: Integrity Implant Abutment 5.0mm x 30 degree -7mm Height
• 00083208950155: Integrity Implant Abutment 5.0mm x 15 degree -7mm Height
• 00083208950001: Integrity Implant Abutment 5.0mm x 0 degree -7mm Height
• 00083208945304: Integrity Implant Abutment 4.5mm x 30 degree -7mm Height
• 00083208945151: Integrity Implant Abutment 4.5mm x 15 degree -7mm Height
• 00083208945007: Integrity Implant Abutment 4.5mm x 0 degree -7mm Height
• 00083208940309: Integrity Implant Abutment 4.0mm x 30 degree -7mm Height
• 00083208940156: Integrity Implant Abutment 4.0mm x 15 degree -7mm Height
• 00083208940002: Integrity Implant Abutment 4.0mm x 0 degree -7mm Height
• 00083208937309: Integrity Implant Abutment 3.7mm x 30 degree -7mm Height
• 00083208937156: Integrity Implant Abutment 3.7mm x 15 degree -7mm Height
• 00083208937002: Integrity Implant Abutment 3.7mm x 0 degree -7mm Height