Harvard PremiumSil Mono Fast

GUDID EHAR70837221

Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2

Harvard Dental International GmbH

Silicone dental impression material
Primary Device IDEHAR70837221
NIH Device Record Key5c5b2227-85ea-4eef-967b-a24bc6297669
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard PremiumSil Mono Fast
Version Model Number7083722
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 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
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de
Phone+493099289780
Emailinfo@harvard-dental-international.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC7083722 [Unit of Use]
HIBCCEHAR70837221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

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 Date2016-09-15

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 Fast2018-07-06Vinylpolysiloxane 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

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