Harvard Ionoglas Fill Extra OptiCaps A2

GUDID EHAR177291

Esthetic glass ionomer cement for restorations

Harvard Dental International GmbH

Glass ionomer dental cement
Primary Device IDEHAR177291
NIH Device Record Key4df2acc6-620b-4a07-9ac2-b36c2546d70e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard Ionoglas Fill Extra OptiCaps A2
Version Model Number17729
Company DUNS341553293
Company NameHarvard Dental International GmbH
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+493099289780
Emailinfo@harvard-dental-international.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC17729M [Unit of Use]
HIBCCEHAR177291 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-18

On-Brand Devices [Harvard Ionoglas Fill Extra OptiCaps A2]

EHAR70522521Esthetic glass ionomer cement for restorations
EHAR177291Esthetic glass ionomer cement for restorations

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