| Primary Device ID | EFSM120080 |
| NIH Device Record Key | 56bb650b-45f4-46c0-82eb-afef2957728f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxford Cem IMPLANT |
| Version Model Number | 12-008 |
| Company DUNS | 341553292 |
| Company Name | First Scientific Dental Materials GmbH |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de | |
| Phone | +4904121909508 |
| info@oxford-scientific.de |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 20 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EFSM120080 [Primary] |
| EMA | Cement, 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 | 2020-09-14 |
| Device Publish Date | 2020-09-06 |
| EFSM100070 - Oxford SpheriChrome | 2022-03-14 One Material Thousand Shades - Light Cure Restorative Composite |
| EFSM100100 - Oxford SpheriBlokk | 2022-03-14 Blocker for Oxford SpheriChrome - Light Cure Restorative Composite |
| EFSM12001BLUE0 - Oxford Zircore NANO Blue | 2020-12-02 Premium Dual cure Core Build-up and Post Cementing Composite |
| EFSM12005A30 - Oxford Flo CEM A3 | 2020-12-02 Dual Cure Flowable Composite Cement |
| E12013A2 - Oxford Zircore NANO A2 | 2020-12-02 Premium Dual cure Core Build-up and Post Cementing Composite |
| E15002 - Oxford Root FILL System | 2020-12-02 Dual Cure Permanent Root Canal Sealing and Filling Material |
| EFSM210050 - Oxford Universal Bond | 2020-12-02 Universal Adhesive |
| EFSM30001A30 - Oxford Temp A3 | 2020-12-02 Temporary Crown & Bridge Material 10:1 |