s-Clean Abutment Screw s-Line Mini

GUDID 08800053027694

Dental Implant System / s-Clean Abutment Screw s-Line Mini (2DSASM)

DENTIS CO. ,LTD

Dental prosthesis/implant abutment screw

• Primary Device ID: 08800053027694
• NIH Device Record Key: 97683f4f-b569-4e7b-b7a8-7d22ae4a705a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Abutment Screw s-Line Mini
• Version Model Number: 2DSASM
• 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	08800053027694 [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

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

[08800053027694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-04
• Device Publish Date: 2022-06-24

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• 08800053064736 - I-FIX Angled Type ScanBody: 2024-11-26 I-FIX Angled Type ScanBody (DFASBL)
• 08800053064743 - I-FIX Angled Type ScanBody Screw: 2024-11-26 I-FIX Angled Type ScanBody Screw (DFSBS)
• 08800053064750 - I-FIX Angled Type ScanBody: 2024-11-26 I-FIX Angled Type ScanBody (DFASBSS)
• 08800053064767 - I-FIX Angled Type ScanBody: 2024-11-26 I-FIX Angled Type ScanBody (DFASBLS)
• 08800053093743 - S250 Series(Ceiling, Mobile): 2024-11-07 AC 100-240V, 50/60HZ, 61-94VA