| Primary Device ID | D701LLE32 |
| NIH Device Record Key | 1bac67c8-51d5-481a-98eb-db412fe65525 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lime Lite Enhanced |
| Version Model Number | LLE3 |
| Company DUNS | 001006089 |
| Company Name | PULPDENT CORPORATION |
| 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 | false |
| 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 |
| Total Volume | 3 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D701LLE32 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2018-08-10 |
| D701SUNO2 - DENTASTIC UNO SAMPLE | 2024-02-16 Adhesive, dentine, applicator brush |
| D701SVPFA32 - Activa Presto | 2023-06-30 .6 mL sample A3 shade + 5 tips |
| D701SVPFA352 - Activa Presto | 2023-06-30 .6 mL sample A3.5 shade + 5 tips |
| D701SVPFA42 - Activa Presto | 2023-06-30 .6 mL sample A4 shade + 5 tips |
| D701SVPFA62 - Activa Presto | 2023-06-30 .6 mL sample A6 shade + 5 tips |
| D701SVPFB12 - Activa Presto | 2023-06-30 .6 mL sample B1 shade + 5 tips |
| D701TTP502 - Tuff Temp Plus Provisional Veneer, Crown, and Bridge Resin | 2021-10-29 50 mL automix syringe cartridge with ten applicator tips |
| D701TTP50A12 - TUFF-TEMP PLUS | 2021-10-29 TUFF-TEMP PLUS A1 SHADE 50 ml cartridge + 10 tips only |