i-Clean Temporary Abutment

GUDID 08800053078252

Dental Implant System / i-Clean Temporary Abutment

DENTIS CO. ,LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800053078252
• NIH Device Record Key: 4b24ecd7-c757-41eb-8778-918008a7449a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Temporary Abutment
• Version Model Number: DITA40O
• 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	08800053078252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

[08800053078252]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-12
• Device Publish Date: 2022-12-02

On-Brand Devices [i-Clean Temporary Abutment]

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• 08800053078399: Dental Implant System / i-Clean Temporary Abutment
• 08800053078382: Dental Implant System / i-Clean Temporary Abutment
• 08800053078375: Dental Implant System / i-Clean Temporary Abutment
• 08800053078368: Dental Implant System / i-Clean Temporary Abutment
• 08800053078351: Dental Implant System / i-Clean Temporary Abutment
• 08800053078344: Dental Implant System / i-Clean Temporary Abutment
• 08800053078337: Dental Implant System / i-Clean Temporary Abutment
• 08800053078320: Dental Implant System / i-Clean Temporary Abutment
• 08800053078313: Dental Implant System / i-Clean Temporary Abutment
• 08800053078306: Dental Implant System / i-Clean Temporary Abutment
• 08800053078290: Dental Implant System / i-Clean Temporary Abutment
• 08800053078283: Dental Implant System / i-Clean Temporary Abutment
• 08800053078276: Dental Implant System / i-Clean Temporary Abutment
• 08800053078269: Dental Implant System / i-Clean Temporary Abutment
• 08800053078252: Dental Implant System / i-Clean Temporary Abutment
• 08800053078245: Dental Implant System / i-Clean Temporary Abutment
• 08800053078238: Dental Implant System / i-Clean Temporary Abutment
• 08800053078221: Dental Implant System / i-Clean Temporary Abutment
• 08800053078214: Dental Implant System / i-Clean Temporary Abutment
• 08800053078207: Dental Implant System / i-Clean Temporary Abutment
• 08800053078191: Dental Implant System / i-Clean Temporary Abutment
• 08800053078184: Dental Implant System / i-Clean Temporary Abutment
• 08800053081023: i-Clean Temporary Abutment (DIPTW40NS)
• 08800053081016: i-Clean Temporary Abutment (DIPTW30NS)
• 08800053081009: i-Clean Temporary Abutment (DIPTW20NS)
• 08800053080996: i-Clean Temporary Abutment (DIPTW10NS)
• 08800053080989: i-Clean Temporary Abutment (DIPTW40OS)
• 08800053080972: i-Clean Temporary Abutment (DIPTW30OS)
• 08800053080965: i-Clean Temporary Abutment (DIPTW20OS)
• 08800053080958: i-Clean Temporary Abutment (DIPTW10OS)
• 08800053080866: i-Clean Temporary Abutment (DIPTW40N)
• 08800053080859: i-Clean Temporary Abutment (DIPTW30N)
• 08800053080842: i-Clean Temporary Abutment (DIPTW20N)
• 08800053080835: i-Clean Temporary Abutment (DIPTW10N)
• 08800053080828: i-Clean Temporary Abutment (DIPTW40O)
• 08800053080811: i-Clean Temporary Abutment (DIPTW30O)
• 08800053080804: i-Clean Temporary Abutment (DIPTW20O)
• 08800053080798: i-Clean Temporary Abutment (DIPTW10O)