| Primary Device ID | D0019062040 | 
| NIH Device Record Key | 31bd61d9-9453-4892-9b6e-da58f282c402 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Lucitone Digital Print™ | 
| Version Model Number | 3D Denture Resin - Dark Reddish Pink | 
| Catalog Number | 906204 | 
| 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 | false | 
| 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 | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Weight | 1 Kilogram | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | D0019062040 [Primary] | 
| KLE | AGENT, TOOTH BONDING, 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 | 
| D0019062400 | Early Experience Kit | 
| D0019062060 | 3D Denture Resin - Pink Opaque | 
| D0019062050 | 3D Denture Resin - Pink | 
| D0019062040 | 3D Denture Resin - Dark Reddish Pink | 
| D0019062030 | 3D Denture Resin - Light Reddish Pink | 
| D0019062020 | 3D Denture Resin - Light | 
| D0019062010 | 3D Denture Resin - Original Opaque | 
| D0019062000 | 3D Denture Resin - Original Shade | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  LUCITONE DIGITAL PRINT  90747346  not registered Live/Pending | Dentsply Sirona Inc. 2021-06-01 |