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 |