s-Clean Sole Abutment s-Line

GUDID 08800053024099

Dental Implant System / s-Clean Sole Abutment s-Line (DSSAMZ40204)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800053024099
• NIH Device Record Key: 86cbbf58-ec6d-4cf4-87bd-7b5ec97268c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Sole Abutment s-Line
• Version Model Number: DSSAMZ40204
• 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	08800053024099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202773

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

[08800053024099]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [s-Clean Sole Abutment s-Line]

• 08800053024150: Dental Implant System / s-Clean Sole Abutment s-Line (
• 08800053024143: Dental Implant System / s-Clean Sole Abutment s-Line (DSSAMZ45304)
• 08800053024136: Dental Implant System / s-Clean Sole Abutment s-Line (DSSAMZ45204)
• 08800053024112: Dental Implant System / s-Clean Sole Abutment s-Line (DSSAMZ40404)
• 08800053024105: Dental Implant System / s-Clean Sole Abutment s-Line (DSSAMZ40304)
• 08800053024099: Dental Implant System / s-Clean Sole Abutment s-Line (DSSAMZ40204)