IH Temporary Abutment AIHTARH4510

GUDID 08800041350575

SEWON MEDIX IH Temporary Abutment Regular Hex Non-Coating Set Product, Ø4.5x1.0mm

sewon medix Inc.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800041350575
• NIH Device Record Key: dfbed347-673d-4572-9ecf-3115921092f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH Temporary Abutment
• Version Model Number: AIHTARH4510
• Catalog Number: AIHTARH4510
• Company DUNS: 688731065
• Company Name: sewon medix Inc.
• 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	08800041350575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153521

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [IH Temporary Abutment]

• 08800041350575: SEWON MEDIX IH Temporary Abutment Regular Hex Non-Coating Set Product, Ø4.5x1.0mm
• 08800041350513: SEWON MEDIX IH Temporary Abutment Mini Hex Non-Coating Set Product, Ø4.0x1.0mm