SuperLine FXS5014C

GUDID D755FXS5014C0

Endosseous dental implant

DENTIUM USA

Screw endosteal dental implant, two-piece

• Primary Device ID: D755FXS5014C0
• NIH Device Record Key: 0fe71b1c-c12a-4eeb-8bf9-114fc05a75f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperLine
• Version Model Number: FXS5014C
• Catalog Number: FXS5014C
• 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: true
• 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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 5 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.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D755FXS5014C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160965

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: 2
• Public Version Date: 2020-02-12
• Device Publish Date: 2020-01-27

On-Brand Devices [SuperLine]

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• D755FXS70100: Endosseous dental implant
• D755FXS70080: Endosseous dental implant
• D755FXS60120: Endosseous dental implant
• D755FXS60100: Endosseous dental implant
• D755FXS60080: Endosseous dental implant
• D755FXS50140: Endosseous dental implant
• D755FXS50120: Endosseous dental implant
• D755FXS50100: Endosseous dental implant
• D755FXS50080: Endosseous dental implant
• D755FXS45140: Endosseous dental implant
• D755FXS45120: Endosseous dental implant
• D755FXS45100: Endosseous dental implant
• D755FXS45080: Endosseous dental implant
• D755FXS40140: Endosseous dental implant
• D755FXS40120: Endosseous dental implant
• D755FXS40100: Endosseous dental implant
• D755FXS40080: Endosseous dental implant
• D755FXS36140: Endosseous dental implant
• D755FXS36120: Endosseous dental implant
• D755FXS36100: Endosseous dental implant
• D755FXS36080: Endosseous dental implant
• D755FXS7012C0: Endosseous dental implant
• D755FXS7010C0: Endosseous dental implant
• D755FXS7008C0: Endosseous dental implant
• D755FXS6012C0: Endosseous dental implant
• D755FXS6010C0: Endosseous dental implant
• D755FXS6008C0: Endosseous dental implant
• D755FXS5014C0: Endosseous dental implant
• D755FXS5012C0: Endosseous dental implant
• D755FXS5010C0: Endosseous dental implant
• D755FXS5008C0: Endosseous dental implant
• D755FXS4514C0: Endosseous dental implant
• D755FXS4512C0: Endosseous dental implant
• D755FXS4510C0: Endosseous dental implant
• D755FXS4508C0: Endosseous dental implant
• D755FXS4014C0: Endosseous dental implant
• D755FXS4012C0: Endosseous dental implant
• D755FXS4010C0: Endosseous dental implant
• D755FXS4008C0: Endosseous dental implant
• D755FXS3614C0: Endosseous dental implant
• D755FXS3612C0: Endosseous dental implant
• D755FXS3610C0: Endosseous dental implant
• D755FXS3608C0: Endosseous dental implant
• D755FX7012SWC0: Endosseous dental implant
• D755FX7010SWC0: Endosseous dental implant
• D755FX7008SWC0: Endosseous dental implant
• D755FX6012SWC0: Endosseous dental implant
• D755FX6010SWC0: Endosseous dental implant
• D755FX6008SWC0: Endosseous dental implant