Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N)

GUDID 08800053025560

Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N)

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

• Primary Device ID: 08800053025560
• NIH Device Record Key: 56c6eaea-8fd5-4b68-b705-b06aea3fe69d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Implant System / s-Clean Couple Abutment s-Line Mini (DSCAMZ40504N)
• Version Model Number: DSCAMZ40504N
• 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	08800053025560 [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

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

Moist Heat or Steam Sterilization

[08800053025560]

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

Devices Manufactured by DENTIS CO. ,LTD

• 08800053091305 - Luvis Chair (LC700C-chair only): 2024-04-03 A Dental Chair to provide patient supporting and positioning during dental treatment.
• 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