| Primary Device ID | D764B11120501 |
| NIH Device Record Key | d0f2084f-645a-4c7e-8be9-fb1659b38c81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FONA CDR |
| Version Model Number | B1112050 |
| 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 |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com | |
| Phone | (877) 724-4254 |
| customerserviceny@sirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D764B11120501 [Primary] |
| EAP | Unit, X-Ray, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-03 |
| Device Publish Date | 2016-09-09 |
| D764B11120501 | FONA CDR SENSOR SIZE 1 SHIP KIT |
| D764B10730921 | FONA CDR UNIVERSAL HOLDERS STARTER KIT - SIZE 2 |
| D764B10730911 | FONA CDR UNIVERSAL HOLDERS STARTER KIT - SIZE 1 |
| D764B10730701 | FONA CDR UNIVERSAL HOLDERS STARTER KIT |
| D764B22521000 | FONA USB REMOTE ASSY |
| D764B22520001 | FONA USB REMOTE SHIP KIT |
| D764B13121000 | FONA CDR SENSOR SIZE 0 |
| D764B13120501 | FONA CDR SENSOR SIZE 0 SHIP KIT |
| D764B12121000 | FONA CDR SENSOR SIZE 2 |
| D764B12120501 | FONA CDR SENSOR SIZE 2 SHIP KIT |
| D764B11121000 | FONA CDR SENSOR SIZE 1 |