s-Clean MU Straight Abutment Mini

GUDID 08800053033497

Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM55S)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800053033497
• NIH Device Record Key: ee8a8736-75da-469b-802e-cf1d2b1a3e70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean MU Straight Abutment Mini
• Version Model Number: DSMUSM55S
• 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	08800053033497 [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

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

[08800053033497]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-01
• Device Publish Date: 2022-06-23

On-Brand Devices [s-Clean MU Straight Abutment Mini]

• 08800053033534: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM15S)
• 08800053033527: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM25S)
• 08800053033510: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM35S)
• 08800053033503: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM45S)
• 08800053033497: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM55S)
• 08800053033473: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM15)
• 08800053033466: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM25)
• 08800053033459: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM35)
• 08800053033442: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM45)
• 08800053033435: Dental Implant System / s-Clean MU Straight Abutment Mini (DSMUSM55)