| Primary Device ID | E241BL0360 |
| NIH Device Record Key | 8860b984-f524-4e36-a04a-8459e19ac2ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cavex Individual Trays uppers plain Xlarge |
| Version Model Number | BL036 |
| Catalog Number | BL036 |
| Company DUNS | 419980156 |
| Company Name | Cavex Holland B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | +31(0)235307700 |
| r.woortman@cavex.nl |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E241BL0360 [Primary] |
| EEA | Plate, Base, Shellac |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-07 |
| E241AA6000 - Cavex Cream | 2018-07-06 Dental Alginate Impression material |
| E241AA6001 - Cavex Cream | 2018-07-06 Dental Alginate Impression material |
| E241CE0900 - Cavex Temporary Cement | 2018-07-06 Dental Cement |
| E241AA0200 - Cavex CA37 Fast Set | 2018-03-29 Dental Alginate Impression material |
| E241AA0201 - Cavex CA37 Fast Set | 2018-03-29 Dental Alginate Impression material |
| E241AA0250 - Cavex CA37 Fast Set | 2018-03-29 Dental Alginate Impression material |
| E241AA0251 - Cavex CA37 Fast Set | 2018-03-29 Dental Alginate Impression material |
| E241AA0350 - Cavex CA37 Fast Set | 2018-03-29 Dental Alginate Impression material |