I-FIX Angled Abutment

GUDID 08806169186065

I-FIX Angled Abutment / DMAA15S

DENTIS CO. ,LTD

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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• 08800266940063 - SQ Step Drill: 2024-10-18 SQ Step Drill / DSQSTD4520
• 08800266940070 - SQ Step Drill: 2024-10-18 SQ Step Drill / DSQSTD5020
• 08800266940087 - SQ Step Drill: 2024-10-18 SQ Step Drill / DSQSTD5520
• 08800053083249 - Luvis Chair (LC700C): 2024-09-27 Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This Device includes a dental
• 08800053099318 - Drill Holder: 2024-08-28 Drill Holder (DDH53)
• 08800266940094 - SQ Guide Long Drill: 2024-08-28 SQ Guide Long Drill (DSQGLD)