| Primary Device ID | D701FLEX2 |
| NIH Device Record Key | 0a9899ef-eaa1-4553-a9c8-4025e17a935f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flexible Scaler |
| Version Model Number | FLEX |
| Company DUNS | 001006089 |
| Company Name | PULPDENT CORPORATION |
| 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 | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D701FLEX2 [Primary] |
| EMN | Scaler, Periodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-01 |
| Device Publish Date | 2021-09-23 |
| 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 |