i-Clean Abutment Screw

GUDID 08806169131522

i-Clean Abutment Screw (DIAS)

DENTIS CO. ,LTD

Dental prosthesis/implant abutment screw

• Primary Device ID: 08806169131522
• NIH Device Record Key: ce3303bd-1472-4746-8062-11199eb78845
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Abutment Screw
• Version Model Number: DIAS
• 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	08806169131522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230307

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

[08806169131522]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

Devices Manufactured by DENTIS CO. ,LTD

• 08800053070553 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM03O)
• 08800053070560 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM04O)
• 08800053070577 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM05O)
• 08800053070584 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM06O)
• 08800053070591 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM07O)
• 08800053070706 - s-Clean ScanHealing Abutment: 2024-08-08 s-Clean ScanHealing Abutment (DSSH4820S)
• 08800053070713 - s-Clean ScanHealing Abutment: 2024-08-08 s-Clean ScanHealing Abutment (DSSH4830S)
• 08800053070720 - s-Clean ScanHealing Abutment: 2024-08-08 s-Clean ScanHealing Abutment (DSSH4840S)