VITA ENAMIC GLAZE M70010

GUDID E239M700101

Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20 ml bottle.

Innovation MediTech GmbH

Polymer-based dental model material
Primary Device IDE239M700101
NIH Device Record Key1115bcef-6505-47df-85b1-0924873df0a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITA ENAMIC GLAZE
Version Model Number1
Catalog NumberM70010
Company DUNS313785693
Company NameInnovation MediTech GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE239M700101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBDCoating, Filling Material, 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 Date2016-10-18

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E239M700101 - VITA ENAMIC GLAZE2018-07-06Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20 ml bottle.
E239M700101 - VITA ENAMIC GLAZE2018-07-06 Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20

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