| Primary Device ID | D764B10731041 |
| NIH Device Record Key | 43ac37fb-2a3c-4a42-9aa5-36b80f5a379a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Holders |
| Version Model Number | B1073104 |
| Company DUNS | 078613913 |
| Company Name | SIRONA DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | 800.659.5977 |
| imagingsupportus@dentsplysirona.com | |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com | |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com | |
| Phone | 800.659.5977 |
| imagingsupportus@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D764B10731041 [Primary] |
| EGZ | Holder, Film, X-Ray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| D764B10731081 | Universal Anterior Holder - Blue |
| D764B10731071 | Universal Bitewing Holder - Red |
| D764B10731061 | Universal Endodontic Holder |
| D764B10731041 | Universal Anterior Holder |
| D764B10731031 | Universal Endodontic Tab Holder |
| D764B10731021 | Universal Bitewing Holder |
| D764B10731011 | Universal Bite Tab Holder |
| D764B10730621 | UNIVERSAL HOLDERS STARTER KIT |