One Piece Dental Implant Small Ball Head ITO 3.0x25mm (SB)

GUDID 00083208230257

One Piece Dental Implant 3.0 mm diameter and 25mm length Small Ball Head

Suncoast Dental, Inc

Screw endosteal dental implant, one-piece

• Primary Device ID: 00083208230257
• NIH Device Record Key: 40cc93ed-b5a5-444a-ad09-9de6d5138c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Piece Dental Implant Small Ball Head
• Version Model Number: ITO 3.0x25mm (SB)
• Catalog Number: ITO 3.0x25mm (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: 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: true

Customer Support Contacts

• Phone: +1 (727)536-4880
• Email: tatumimplants@verizon.net

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208230257 [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

[00083208230257]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [One Piece Dental Implant Small Ball Head]

• 00083208235252: One Piece Dental Implant 3.5 mm diameter and 25mm length Small Ball Head
• 00083208230257: One Piece Dental Implant 3.0 mm diameter and 25mm length Small Ball Head