Device
Temp it Flow are Light-Curing Flowable Temporary Filling Material. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy re...
Manufacturer
Spident Co., Ltd.
Model: Temp it Flow+ Blu 4ea DI: 08809262959017 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
Temp it Flow are Light-Curing Flowable Temporary Filling Material. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 91672182-208d-400b-bf43-4b5aaed16156
Distribution Status: In Commercial Distribution
DUNS Number: 689370711
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08809262959017
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35870
Name: Dental composite resin
Definition:
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
FDA Product Codes
EBF
Material, Tooth Shade, Resin