| Primary Device ID | D661600111780 |
| NIH Device Record Key | 613a0c2d-dec0-4e8b-a9af-62a5e0234097 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CanalPro |
| Version Model Number | 60011178 |
| Company DUNS | 622185718 |
| Company Name | COLTENE/WHALEDENT INC |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D661600111780 [Primary] |
| KYX | Dispenser, Liquid Medication |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-10-29 |
| Device Publish Date | 2019-02-11 |
| D661600235260 | Endo-Ice Green |
| D661600111780 | CanalPro Syringe Station |
| 10840016202053 | Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black pr |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CANALPRO 85688586 4312443 Live/Registered |
Coltène/Whaledent GmbH + Co. KG 2012-07-27 |
![]() CANALPRO 85240291 4212326 Live/Registered |
Coltène/Whaledent GmbH + Co. KG 2011-02-11 |
![]() CANALPRO 79384555 not registered Live/Pending |
Coltène/Whaledent AG 2023-10-05 |