VITA ENAMIC STAIN blue M700124

GUDID E239M7001241

Colour powder for shade customization and characterization of the surface of dental restorations. 2 g bottle.

Innovation MediTech GmbH

Polymer-based dental model material
Primary Device IDE239M7001241
NIH Device Record Key29902c1f-9108-4a4f-b1f6-3e69ee80f781
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITA ENAMIC STAIN blue
Version Model Number1
Catalog NumberM700124
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
HIBCCE239M7001241 [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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