| Primary Device ID | D0019062240 |
| NIH Device Record Key | cce44a52-bed3-48a7-96a6-3917122578c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lucitone Digital Try-In™ |
| Version Model Number | 3D Trial Placement Resin - B2 |
| Catalog Number | 906224 |
| 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 | D0019062240 [Primary] |
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| 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 |
| D0019062250 | 3D Trial Placement Resin - BL3 |
| D0019062240 | 3D Trial Placement Resin - B2 |
| D0019062230 | 3D Trial Placement Resin - B1 |
| D0019062220 | 3D Trial Placement Resin - A3 |
| D0019062210 | 3D Trial Placement Resin - A2 |
| D0019062200 | 3D Trial Placement Resin - A1 |