Multi-unit Transfer Impression Coping MTIC480

GUDID 08800041356225

SEWON MEDIX IH Multi-unit Transfer Impression Coping 1Piece Bridge, Ø4.8x8.0mm

sewon medix Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800041356225
• NIH Device Record Key: cd55c516-9ab2-4b05-9f31-2c610253ce61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-unit Transfer Impression Coping
• Version Model Number: MTIC480
• Catalog Number: MTIC480
• 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

Customer Support Contacts

• Phone: +1-224-531-3099
• Email: hsong@mydental.com

Device Dimensions

• Stent Diameter: 4.8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041356225 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-11-09

Devices Manufactured by sewon medix Inc.

• 08800041365098 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x8.5mm
• 08800041365104 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm
• 08800041365111 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x11.5mm
• 08800041365128 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x13.0mm
• 08800041365135 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x15.0mm
• 08800041365142 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x7.0mm
• 08800041365159 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x8.5mm
• 08800041365166 - XP-I SLA Fixture: 2022-02-24 SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x10.0mm