| Primary Device ID | E241BW0850 |
| NIH Device Record Key | 9ec72517-e7fd-4fef-a620-89e346a44601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cavex Boil&Bite |
| Version Model Number | BW085 |
| Catalog Number | BW085 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E241BW0850 [Primary] |
| EEG | Heat Source For Bleaching Teeth |
| 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 |
| E241AA9050 - Cavex CleverCast - Slow Set | 2026-03-13 Lifecast Alginate Impression material |
| 08719327516010 - Cavex CleverCast - Normal Set | 2026-03-13 Lifecast Alginate Impression material |
| E241BW0070 - Cavex Bite&White 3 syringes CP16 | 2026-03-13 Dental Whitening Agent |
| E241BW0080 - Cavex Bite&White 3 syringes CP22 | 2026-03-13 Dental Whitening Agent |
| E241BW0310 - Cavex Bite&White Ready 2 Use | 2026-03-13 Dental Whitening Agent |
| E241BW0500 - Cavex Bite&White In-Office 25% Starter | 2026-03-13 Dental Whitening Agent |
| E241BW0510 - Cavex Bite&White In-Office 25% Pen bulk | 2026-03-13 Dental Whitening Agent |
| E241BW0520 - Cavex Bite&White In-Office 25% Barrier bulk | 2026-03-13 Dental Whitening Agent |