| Primary Device ID | D68601312612 |
| NIH Device Record Key | 7d20d1b0-5441-4be9-82b4-3bc5d55fb660 |
| Commercial Distribution Discontinuation | 2023-04-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Waterpik Key-To Alginate Impression Material |
| Version Model Number | 013126-000 |
| Catalog Number | 013126-000 |
| Company DUNS | 001804074 |
| Company Name | WATER PIK, 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 | 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D68601312612 [Primary] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-04-24 |
| Device Publish Date | 2016-08-02 |
| D68601312612 | Alginate Impression Material, Heavy Body - Fast Set, 25lb (11.34kg) drum |
| D68601311396 | Alginate Impression Material, Regular Body - Fast Set, 1lb (454g) can |
| D68601311295 | Alginate Impression Material, Heavy Body - Fast Set, 1lb (454g) can |
| D68601311194 | Alginate Impression Material, Regular Body - Regular Set, 1lb (454g) can |
| D6860131261 | Heavy Body, Fast Set |
| D6860131139 | Regular Body, Fast Set |
| D6860131129 | Heavy Body, Fast Set |
| D6860131119 | Regular Body, Regular Set |