| Primary Device ID | D701RSTR2 |
| NIH Device Record Key | ca371e84-c5b6-4dda-b9c7-f56cc6179192 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo Ruler |
| Version Model Number | RST-R |
| 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 | D701RSTR2 [Primary] |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments |
| 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 |
| D701T20G191 - Applicator Tips | 2024-12-11 Automix Tips, clear, with bendable 19-gauge metal cannula - Pkg of 20 |
| D701SVBFUS2 - ACTIVA™ BioACTIVE Bulk Flow | 2024-12-10 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample |
| D701SVKBFUS2 - ACTIVA™ Kids BioACTIVE Bulk Flow | 2024-12-10 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample |
| D701VBF1US2 - ACTIVA™ BioACTIVE Bulk Flow | 2024-12-10 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion) |
| D701VKBF1OW2 - ACTIVA™ Kids BioACTIVE Bulk Flow | 2024-12-10 1 x 3mL / 5gm syringe + 10 Automix tips, opaque white shade |
| D710VKBF1US2 - ACTIVA™ Kids BioACTIVE Bulk Flow | 2024-12-10 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion) |
| D701SUNO2 - DENTASTIC UNO SAMPLE | 2024-02-16 Adhesive, dentine, applicator brush |
| D701SVPFA32 - Activa Presto | 2023-06-30 .6 mL sample A3 shade + 5 tips |