I-FIX Angled Abutment

GUDID 08806169186065

I-FIX Angled Abutment / DMAA15S

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

• Primary Device ID: 08806169186065
• NIH Device Record Key: a5227859-2c31-4f8a-a8a3-17e1fdd642ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-FIX Angled Abutment
• Version Model Number: DMAA15S
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08806169186065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083586

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

[08806169186065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-16
• Device Publish Date: 2023-05-08

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