Tatum Surgical-ITO Small Ball Analog Analog ITO 3.0-5.0 (SB)

GUDID 00083208104619

Tatum One-Piece Analog for Small Ball Implants and abutments - size 3.0-5.0mm

Suncoast Dental, Inc

Dental implant analog

• Primary Device ID: 00083208104619
• NIH Device Record Key: 34190edd-7f7f-4ed0-b193-972affb981a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical-ITO Small Ball Analog
• Version Model Number: Analog (SB) 3.0-5.0
• Catalog Number: Analog ITO 3.0-5.0 (SB)
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208104619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

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