SuperLine FX4012SWC

GUDID D755FX4012SWC0

Endosseous dental implant

DENTIUM USA

Screw endosteal dental implant, two-piece

• Primary Device ID: D755FX4012SWC0
• NIH Device Record Key: 2e450524-06d1-4969-996b-a4a576a4e1af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperLine
• Version Model Number: FX4012SWC
• Catalog Number: FX4012SWC
• 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: false
• 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
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com
• Phone: +1(714)226-0229
• Email: cs@dentiumusa.com

Device Dimensions

• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D755FX4012SWC0 [Primary]

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: 2021-11-22
• Device Publish Date: 2015-10-29

On-Brand Devices [SuperLine]

• D755FXS70120: Endosseous dental implant
• 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