Primary Device ID | D701TTP502 |
NIH Device Record Key | 836defcd-d385-45cd-b583-2dbca2f6cfb4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tuff Temp Plus Provisional Veneer, Crown, and Bridge Resin |
Version Model Number | TTP50 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D701TTP502 [Primary] |
EBG | Crown And Bridge, Temporary, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-10-29 |
Device Publish Date | 2018-12-14 |
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 | 2021-10-2950 mL automix syringe cartridge with ten applicator 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 |