| Primary Device ID | D6919011005 |
| NIH Device Record Key | d63861e0-ff65-4b93-89b3-3dc18fef36e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Removalon |
| Version Model Number | 9011005 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D6919011005 [Primary] |
| FLG | Cleaner, Ultrasonic, Medical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-07 |
| Device Publish Date | 2022-06-29 |
| D6919011005 | REMOVALON I DRY PK CASEOF 6 |
| D6918101998 | REMOVALON I DRY PK SINGLE |
| 00348783003864 | REMOVALON I DRY PK CASEOF 6 |
| 00348783003857 | REMOVALON I DRY PK SINGLE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REMOVALON 73137959 1097123 Live/Registered |
PREMIER DENTAL PRODUCTS COMPANY 1977-08-18 |