s-Clean Zero Margin Abutment

GUDID 08806169193025

Dental Implant Abutment / s-Clean Zero Margin Abutment SET

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169193025
• NIH Device Record Key: 604755cc-1f22-4376-88cc-bab57ae42230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Zero Margin Abutment
• Version Model Number: DSZAAS
• 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	08806169193025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111364

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

[08806169193025]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-08
• Device Publish Date: 2021-05-31

Devices Manufactured by DENTIS CO. ,LTD

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• 08806169138965 - s-Clean Ratchet Driver: 2024-04-02 s-Clean Ratchet Driver (DRMDSEL)
• 08800053082808 - MESHEET075: 2024-03-13 MESHEET075
• 08800053082815 - MESHEET075-R: 2024-03-13
• 08800053042093 - DENOPS: 2024-01-31 DC : 3.7 V, 550mh(Battery)
• 08800053045032 - LUVIS-C600 Series: 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
• 08800053045049 - LUVIS-C600 Series: 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
• 08800053045056 - LUVIS-C600 Series: 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA