| Primary Device ID | 07350052430182 |
| NIH Device Record Key | fdb09e54-3a8c-4564-ac29-bfc2c2ab1639 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ceramir Applicator 2 |
| Version Model Number | 40027 |
| Catalog Number | 40027 |
| Company DUNS | 350486340 |
| Company Name | Doxa Dental AB |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com | |
| Phone | 1.855.369-2827 |
| info@ceramirUS.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350052430182 [Primary] |
| EJB | Handle, Instrument, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| 07350052430182 - Ceramir Applicator 2 | 2023-06-16 |
| 07350052430182 - Ceramir Applicator 2 | 2023-06-16 |
| 07350052430380 - Ceramir® Protect LC Syringe | 2021-07-19 |
| 07350052430403 - Ceramir® Protect LC Syringe | 2021-07-19 |
| 07350052430311 - Ceramir® Restore QuikCap | 2021-01-08 |
| 07350052430298 - Ceramir Bioceramic Implant Cement QuikCap | 2019-03-28 |
| 07350052430151 - Ceramir Crown & Bridge QuikCap | 2018-09-17 |
| 07350052430168 - Ceramir Crown & Bridge QuikCap | 2018-09-17 |
| 07350052430175 - Ceramir Crown & Bridge QuikCap | 2018-09-17 |