TatumSurgical/Screw Implant IS8.0x20

GUDID 00083208580208

Screw Dental Implant 8.0mm in diameter and 20mm in length

Suncoast Dental, Inc

Screw endosteal dental implant, two-piece

• Primary Device ID: 00083208580208
• NIH Device Record Key: d5bf2393-ac70-45d2-8c05-37b44c640ccd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TatumSurgical/Screw Implant
• Version Model Number: Screw/8.0 x 20
• Catalog Number: IS8.0x20
• 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: 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

• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208580208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00083208580208]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-21
• Device Publish Date: 2019-06-13

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