s-Clean Couple Abutment s-Line Mini

GUDID 08800053028769

Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ55407HS)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800053028769
• NIH Device Record Key: 28d8513b-2246-4194-a82d-2552494ad1f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Couple Abutment s-Line Mini
• Version Model Number: DSCAMZ55407HS
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800053028769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210080

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

[08800053028769]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-05
• Device Publish Date: 2022-06-27

On-Brand Devices [s-Clean Couple Abutment s-Line Mini]

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• 08800053025737: Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ5520N)
• 08800053025720: Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ4550N)
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• 08800053025652: Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ4020N)
• 08800053025645: Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ55504N)
• 08800053025638: Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ55404N)
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