XDR CLARITY
GUDID D787XDR4P20ADSZ20
XDR CLARITY - Size-2 Digital Intraoral Sensor
CYBER MEDICAL IMAGING, INC.
Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral 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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