| Primary Device ID | D8139094L0 |
| NIH Device Record Key | 21afa121-f566-487c-a198-946249801607 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rotadent® |
| Version Model Number | 9094L |
| Catalog Number | 9094L |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 2 |
| 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 | true |
| 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 |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8139094L0 [Unit of Use] |
| HIBCC | D8139094L1 [Primary] |
| JEQ | Toothbrush, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-30 |
| Device Publish Date | 2022-09-22 |
| D8139094S0 | RD PLUS SHORT TIP BRSHD 2PK |
| D8139094L0 | RD PLUS LONG TIP BRSHD 2PK |
| D8139094H1 | RD PLUS HOLLOW TIP BRSHD 2PK |
| D8139090S0 | RD CLASSIC SHORT TIP BRSHD BLK |
| D8139090L0 | RD CLASSIC LONG TIP BRSHD BLK |
| D8139090H0 | RD CLASS HOLLOW TIP BRSHD BLK |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ROTADENT 73504340 1340479 Dead/Cancelled |
DENTALBORRFABRIKEN AB 1984-10-18 |