| Primary Device ID | E239D49701X61 | 
| NIH Device Record Key | a8ebd7ed-9ff7-489b-974a-c1c8353bb0f6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Mixing tips | 
| Version Model Number | D49701X6 | 
| Catalog Number | D49701X6 | 
| Company DUNS | 388000846 | 
| Company Name | Dreve Dentamid GmbH | 
| 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 | 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 | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | |
| Phone | +49230388070 | 
| dentamid@dreve.de | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | E239D49701X61 [Primary] | 
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-07-28 | 
| Device Publish Date | 2025-07-18 | 
| E239D49811 | No. | 
| E239D4970X51 | No. | 
| E239D4970X31 | No. | 
| E239D4970X21 | No. | 
| E239D4970X11 | No. | 
| E239D49701X51 | No. | 
| E239D49701X31 | No. | 
| E239D49701X21 | No. | 
| E239D49701X11 | No. | 
| E239D49701X61 | No. | 
| E239D49701X41 | No. |