XDR CLARITY
GUDID D787XDR4P20ADSZ20
XDR CLARITY - Size-2 Digital Intraoral Sensor
CYBER MEDICAL IMAGING, INC.
Dental digital imaging sensor, intraoral| Primary Device ID | D787XDR4P20ADSZ20 |
| NIH Device Record Key | c5778edf-348e-4a6d-bcd7-46bd5aac612c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XDR CLARITY |
| Version Model Number | XDR4P20SZ2 |
| Company DUNS | 112029934 |
| Company Name | CYBER MEDICAL IMAGING, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com | |
| Phone | 888-937-9729 |
| service@xdrradiology.com |
Device Dimensions
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
| Length | 42.3 Millimeter |
| Width | 30.5 Millimeter |
| Height | 5.4 Millimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Same as Handling Conditions |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D787XDR4P20ADSZ20 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013271
FDA Product Code
| MUH | System, X-Ray, Extraoral Source, Digital |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
[D787XDR4P20ADSZ20]
Liquid Chemical
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-16 |
| Device Publish Date | 2023-05-08 |
On-Brand Devices [XDR CLARITY]
| D787XDR4P20ADSZ20 | XDR CLARITY - Size-2 Digital Intraoral Sensor |
| D787XDR4P10ACSZ10 | XDR CLARITY - Size-1 Digital Intraoral Sensor |
Trademark Results [XDR CLARITY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XDR CLARITY 90765307 not registered Live/Pending |
Cyber Medical Imaging, Inc. 2021-06-09 |
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