| Primary Device ID | D875403051 |
| NIH Device Record Key | d13167d5-0aa7-4389-95df-fdc6abb9dd42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apex Cloud Software |
| Version Model Number | 1 |
| Company DUNS | 017009932 |
| Company Name | MASTERLINK LLC |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (800) 869-0915 |
| sean@dentalsensors.com | |
| Phone | (800) 869-0915 |
| sean@dentalsensors.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D875403051 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-23 |
| D875S11684127104 - Apex | 2018-07-06 Size #1 Pedo Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure. |
| D875S11685127105 - Apex | 2018-07-06 Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure. |
| D875400101 - Apex Capture Software | 2018-03-29 Dental imaging capture, enhance and display software. |
| D875403051 - Apex Cloud Software | 2018-03-29A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device. |
| D875403051 - Apex Cloud Software | 2018-03-29 A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been capt |