| Primary Device ID | D81394000WTYH0 |
| NIH Device Record Key | b843f5b6-565a-4eac-8615-79ebf7e66ea7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rotadent |
| Version Model Number | 94000WTYH |
| Catalog Number | 94000WTYH |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| 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 |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM | |
| Phone | 1-800-433-6628 |
| INFO@DENMAT.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D81394000WTYH0 [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 | 2025-02-27 |
| Device Publish Date | 2025-02-19 |
| 00359883007201 - EVANESCE | 2025-06-09 19g MIXING TIPS 25pk |
| 00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack | 2025-03-26 Gingival Retraction Solution |
| 00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit | 2025-03-26 Gingival Retraction Solution |
| 00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack | 2025-03-24 VPS Impression Material |
| 00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack | 2025-03-21 Wheel, Polishing Agent |
| 00359883006501 - Clinician's Choice® G5 Sample Pack | 2025-03-21 Dental coating, tooth-desensitizing, professional |
| 00359883000608 - PowerMix™ Automatic Impression Material Dispenser | 2025-03-20 Two-component dental material applicator, electric |
| 00359883000615 - PowerMix™ Dynamic Mixing Tips | 2025-03-20 Dental material mixing nozzle, non-sterile |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ROTADENT 73504340 1340479 Dead/Cancelled |
DENTALBORRFABRIKEN AB 1984-10-18 |