SuperLine FXS5012C

GUDID D755FXS5012C0

Endosseous dental implant

DENTIUM USA

Screw endosteal dental implant, two-piece

• Primary Device ID: D755FXS5012C0
• NIH Device Record Key: fa46c4d8-ce47-4fb2-a378-3b29ba210f68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperLine
• Version Model Number: FXS5012C
• Catalog Number: FXS5012C
• 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

Device Dimensions

• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D755FXS5012C0 [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: 2
• Public Version Date: 2020-02-12
• Device Publish Date: 2020-01-27

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• D755FXS50140: Endosseous dental implant
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• D755FXS50100: Endosseous dental implant
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• D755FXS45120: Endosseous dental implant
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• D755FXS40140: Endosseous dental implant
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• D755FXS40100: Endosseous dental implant
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• D755FXS5010C0: Endosseous dental implant
• D755FXS5008C0: Endosseous dental implant
• D755FXS4514C0: Endosseous dental implant
• D755FXS4512C0: Endosseous dental implant
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• D755FXS4014C0: Endosseous dental implant
• D755FXS4012C0: Endosseous dental implant
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• D755FX7010SWC0: Endosseous dental implant
• D755FX7008SWC0: Endosseous dental implant
• D755FX6012SWC0: Endosseous dental implant
• D755FX6010SWC0: Endosseous dental implant
• D755FX6008SWC0: Endosseous dental implant