Acrytemp CB A3 C700215

GUDID EZHIC7002151

Dental Composite Material

ZHERMACK SPA

Dental appliance fabrication material, cured
Primary Device IDEZHIC7002151
NIH Device Record Key5a721407-a5f8-4d0e-83d8-64c28b5822a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcrytemp CB A3
Version Model NumberC700215
Catalog NumberC700215
Company DUNS432971034
Company NameZHERMACK SPA
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com

Device Dimensions

Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEZHIC7002151 [Primary]

FDA Product Code

EBGCROWN AND BRIDGE, TEMPORARY, 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 Date2016-09-09

Devices Manufactured by ZHERMACK SPA

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EZHIC2020861 - Mixing Tips2022-06-22 Mixing Tips
EZHIC2020901 - Mixing Tips2022-06-22 Oral Tips
EZHIC2032331 - Mixing Tips2022-06-22 Mixing Tip
EZHIC2055001 - Mixing Tips2022-06-22 Mixing Tip
EZHIC2055301 - Dynamic-static Mixing Tips2022-06-22 Dynamic-static Mixing Tips

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