Implantium FX3808MLC

GUDID D755FX3808MLC0

Endosseous dental implant

DENTIUM USA

Screw endosteal dental implant, two-piece

• Primary Device ID: D755FX3808MLC0
• NIH Device Record Key: 7c49c024-fd02-4288-b4e8-dbf508dc1885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implantium
• Version Model Number: FX3808MLC
• Catalog Number: FX3808MLC
• Company DUNS: 079689366
• Company Name: DENTIUM USA
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com

Device Dimensions

• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 8 Millimeter
• Outer Diameter: 4 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored and transported in a dry condition in the original package at room temperature and kept away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D755FX3808MLC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041368

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-01-06
• Device Publish Date: 2015-10-29

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