| Primary Device ID | E241BL0060 | 
| NIH Device Record Key | c640a5d0-dd29-4f7a-bcf3-0846a25fdc26 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cavex Individual Trays uppers plain | 
| Version Model Number | BL060 | 
| Catalog Number | BL060 | 
| 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 | E241BL0060 [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 |