Harvard PremiumSil Putty Fast

GUDID EHAR70837521

Vinylpolysiloxane impression material, Putty, kneadable, type 0

Harvard Dental International GmbH

Silicone dental impression material
Primary Device IDEHAR70837521
NIH Device Record Key36f771b1-09c9-48fe-abce-ab5ee2b968e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarvard PremiumSil Putty Fast
Version Model Number7083752
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
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
HIBCCEHAR70837521 [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 Fast2018-07-06 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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