i900 Series Single Use Tip

GUDID 18800026700873

i900 Series Single-Use Tip

Medit Corp.

Intraoral optical scanning system

• Primary Device ID: 18800026700873
• NIH Device Record Key: 643cb9e9-391e-4f24-b984-204b1ba4efc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i900 Series Single Use Tip
• Version Model Number: MO1-ST1
• Company DUNS: 688800085
• Company Name: Medit Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: +82221939600
• Email: support@medit.com
• Phone: +82221939600
• Email: support@medit.com
• Phone: +82221939600
• Email: support@medit.com
• Phone: +82221939600
• Email: support@medit.com
• Phone: +82221939600
• Email: support@medit.com
• Phone: +82221939600
• Email: support@medit.com
• Phone: +82221939600
• Email: support@medit.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal
• Handling Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.8 KiloPascal and 1.1 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026700876 [Primary]
GS1	18800026700873 [Package]; Contains: 08800026700876; Package: Second package [10 Units]; In Commercial Distribution
GS1	28800026700870 [Package]; Package: Third package [5 Units]; In Commercial Distribution

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-11
• Device Publish Date: 2026-02-03

Devices Manufactured by Medit Corp.

• 18800026700873 - i900 Series Single Use Tip: 2026-02-11i900 Series Single-Use Tip
• 18800026700873 - i900 Series Single Use Tip: 2026-02-11 i900 Series Single-Use Tip
• 08800026700630 - i900 Mobility: 2025-08-04
• 08800026700869 - Medit Orthodontic Suite: 2025-06-06
• 08800026700203 - Medit ClinicCAD: 2024-07-01 SW version: 0.9.x
• 08800026700289 - i900: 2024-04-17
• 08800026700296 - Handpiece Cover: 2024-04-17
• 08800026700302 - Reusable Tip (Medium): 2024-04-17
• 08800026700319 - Reusable Tip (Large): 2024-04-17