coDiagnostiX

GUDID D835CDX202

Dental implant planning software

Dental Wings GmbH

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: D835CDX202
• NIH Device Record Key: 68940839-990a-46e5-a579-b51ab3683d2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: coDiagnostiX
• Version Model Number: 9
• Company DUNS: 342721295
• Company Name: Dental Wings GmbH
• 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: false
• 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: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com
• Phone: 888-856-6997
• Email: coDiagnostiX.Support@dental-wings.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled moisture (no condensation)
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D835CDX1 [Primary]
HIBCC	D835CDX200 [Package]; Contains: D835CDX1; Package: [1 Units]; In Commercial Distribution
HIBCC	D835CDX201 [Package]; Contains: D835CDX1; Package: [20 Units]; In Commercial Distribution
HIBCC	D835CDX202 [Package]; Contains: D835CDX1; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130724

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-17

On-Brand Devices [coDiagnostiX]

• D835CDX202: Dental implant planning software
• D835CODX200: Dental surgery treatment planning software