i-Clean Temporary Abutment

GUDID 08800053078214

Dental Implant System / i-Clean Temporary Abutment

DENTIS CO. ,LTD

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800053078214
• NIH Device Record Key: 742cf073-6979-4ad8-998e-4d7013ac7fce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Temporary Abutment
• Version Model Number: DIOTWN
• 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	08800053078214 [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

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

Moist Heat or Steam Sterilization

[08800053078214]

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

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• 08800053081009: i-Clean Temporary Abutment (DIPTW20NS)
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• 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)