LuxaFlow® Ultra Intro Kit 224000

GUDID EDMG2240001

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 4 syringes @ 1,5 g composite, Accessories. Colors: A1, A2, A3.5, B1

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental composite resin
Primary Device IDEDMG2240001
NIH Device Record Keyc54b1351-4132-4c5b-96d6-d85f18fb9469
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuxaFlow® Ultra Intro Kit
Version Model Number224000
Catalog Number224000
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG2240001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH

EDMG2228291 - Safetip Dispenser Pro2024-07-22 Dispenser for direct application with all commercially available composite tips. e. g. suitable for Ecosite Elements.
EDMG2229010 - Ecosite One2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
EDMG2229020 - Ecosite One2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
EDMG2229001 - Ecosite One2023-11-29 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
EDMG5400050 - DeltaFil2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
EDMG5400060 - DeltaFil2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
EDMG5400100 - DeltaFil2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
EDMG1102661 - Automix-Tips Blue 1:12022-09-09 Automix-Tips Blue 1:1. Suitable for: PermaCem Automix, PermaCem Automix Dual, TempoCem Automix, TempoCem NE Automix. Content: 50

Trademark Results [LuxaFlow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LUXAFLOW
LUXAFLOW
75664524 2483113 Live/Registered
ERNST MUHLBAUER GMBH & CO, KG
1999-03-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.