Multi Straight Abutment

GUDID 08800070222782

Izenimplant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800070222782
• NIH Device Record Key: 0f8af008-0142-4d3c-bf6e-1075806961c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi Straight Abutment
• Version Model Number: MSATR4840S
• Company DUNS: 694625347
• Company Name: Izenimplant 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	08800070222782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211090

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800070222782]

Moist Heat or Steam Sterilization

[08800070222782]

Moist Heat or Steam Sterilization

[08800070222782]

Moist Heat or Steam Sterilization

[08800070222782]

Moist Heat or Steam Sterilization

[08800070222782]

Moist Heat or Steam Sterilization

[08800070222782]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Multi Straight Abutment]

• 08800070222690: MSASR4845S
• 08800070222683: MSASR4835S
• 08800070222676: MSASR4825S
• 08800070222799: MSATR4850S
• 08800070222782: MSATR4840S
• 08800070222775: MSATR4830S
• 08800070222768: MSATR4820S
• 08800070222751: MSATR4810S
• 08800070222744: MSATM4850S
• 08800070222737: MSATM4840S
• 08800070222720: MSATM4830S
• 08800070222713: MSATM4820S
• 08800070222706: MSATM4810S
• 08800070222669: MSASR4815S
• 08800070222195: MSATR4850
• 08800070222188: MSATR4840
• 08800070222171: MSATR4830
• 08800070222164: MSATR4820
• 08800070222157: MSATR4810
• 08800070222140: MSATM4850
• 08800070222133: MSATM4840
• 08800070222126: MSATM4830
• 08800070222119: MSATM4820
• 08800070222102: MSATM4810
• 08800070222096: MSASR4845
• 08800070222089: MSASR4835
• 08800070222072: MSASR4825
• 08800070222065: MSASR4815