Harvard Ionoglas Cem LC, Shade Universal

GUDID EHAR70412151

Resin modified glass ionomer cement for luting and lining, light curing

Harvard Dental International GmbH

Glass ionomer dental cement
Primary Device IDEHAR70412151
NIH Device Record Key7f92d5ba-5854-4014-b0bb-4bdc86c3fe3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard Ionoglas Cem LC, Shade Universal
Version Model Number7041215
Company DUNS341553293
Company NameHarvard Dental International 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

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
HIBCCEHAR70412151 [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

Devices Manufactured by Harvard Dental International GmbH

EHAR70837011 - Harvard PremiumSil Light2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, light bodied, type 3
EHAR70837021 - Harvard PremiumSil Light Fast2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, light bodied, type 3
EHAR70837111 - Harvard PremiumSil Medium2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, medium bodied, type 3
EHAR70837121 - Harvard PremiumSil Medium Fast2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, medium bodied, type 3
EHAR70837211 - Harvard PremiumSil Mono2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2
EHAR70837221 - Harvard PremiumSil Mono Fast2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2
EHAR70837311 - Harvard PremiumSil Heavy2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, heavy bodied, type 2
EHAR70837321 - Harvard PremiumSil Heavy Fast2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, heavy bodied, type 2

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