| Primary Device ID | D6864230535 |
| NIH Device Record Key | 4570f0e7-8a1a-47fd-8389-e936fdce4fa0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waterpik Barrier Dentin Sealant |
| Version Model Number | 042305-000 |
| Catalog Number | 042305-000 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com | |
| Phone | (800) 525-2020 |
| professional@waterpik.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D6864230535 [Primary] |
| LBH | Varnish, Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-07 |
| Device Publish Date | 2016-07-29 |
| D6864230535 | Cavity varnish, Kit containing 15ml of sealant and 50 pipettes. |
| D686423053 | Cavity varnish, coronal sealant for endodontic procedures, and short-term protectant for exposed |