| Primary Device ID | D764B10730581 |
| NIH Device Record Key | 40cb8467-31c9-4bfd-b23b-ea2f36a5f1f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FONA ELITE |
| Version Model Number | B1073058 |
| Company DUNS | 078613913 |
| Company Name | SIRONA DENTAL, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D764B10730581 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2016-09-09 |
| D764B11110001 | FONA ELITE SENSOR SIZE 1 SHIP KIT |
| D764B10730591 | FONA ELITE STARTER KIT SIZE 0 |
| D764B10730581 | FONA ELITE STARTER KIT SIZE 1 |
| D764B10730571 | FONA ELITE STARTER KIT SIZE 2 |
| D764B22721000 | FONA ELITE REMOTE ASSY |
| D764B22720001 | FONA ELITE REMOTE SHIP KIT |
| D764B13111000 | FONA ELITE SENSOR SIZE 0 |
| D764B13110451 | FONA ELITE SENSOR SIZE 0 KIT |
| D764B13110001 | FONA ELITE SENSOR SIZE 0 SHIP KIT |
| D764B12111121 | FONA ELITE REPLACEABLE CABLE KIT 3 FT. |
| D764B12111111 | FONA ELITE REPLACEABLE CABLE KIT 9 FT. |
| D764B12111101 | FONA ELITE REPLACEABLE CABLE KIT 6 FT. |
| D764B12111000 | FONA ELITE SENSOR SIZE 2 |
| D764B12110451 | FONA ELITE SENSOR SIZE 2 KIT |
| D764B12110001 | FONA ELITE SENSOR SIZE 2 SHIP KIT |
| D764B11111000 | FONA ELITE SENSOR SIZE 1 |
| D764B11110451 | FONA ELITE SENSOR SIZE 1 KIT |