| Primary Device ID | D0019062450 |
| NIH Device Record Key | ee8647b2-7148-4c3d-b185-59d712b2b973 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lucitone Digital Fuse™ |
| Version Model Number | Bonding Kit |
| Catalog Number | 906245 |
| Company DUNS | 606173334 |
| Company Name | Dentsply International Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0019062450 [Primary] |
| EBD | Coating, filling material, resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-17 |
| Device Publish Date | 2019-09-09 |
| D0019062450 | Bonding Kit |
| D0019061950 | Step 3 - 3D Denture Sealer |
| D0019061920 | Step 2 - 3D Denture Bonding Agent - Pink Opaque |
| D0019061910 | Step 2 - 3D Denture Bonding Agent - Pink |
| D0019061900 | Step 2 - 3D Denture Bonding Agent - Dark Reddish P |
| D0019061890 | Step 2 - 3D Denture Bonding Agent - Light Reddish |
| D0019061880 | Step 2 - 3D Denture Bonding Agent - Light |
| D0019061870 | Step 2 - 3D Denture Bonding Agent - Original Opaqu |
| D0019061860 | Step 2 - 3D Denture Bonding Agent - Original |
| D0019061850 | Step 1 - 3D Tooth Conditioning Agent |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LUCITONE DIGITAL FUSE 90747320 not registered Live/Pending |
Dentsply Sirona Inc. 2021-06-01 |