coDiagnostiX
GUDID D835CDX202
Dental implant planning software
Dental Wings GmbH
Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation 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
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 |
Trademark Results [coDiagnostiX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODIAGNOSTIX 79098308 4173483 Live/Registered |
Straumann Holding AG 2011-04-29 |
 CODIAGNOSTIX 77263320 not registered Dead/Abandoned |
Anton Josef Voitik 2007-08-24 |
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