Fixtemp C&B D60394

GUDID E239D603941

No.

Dreve Dentamid GmbH

Dental crown/bridge resin, temporary
Primary Device IDE239D603941
NIH Device Record Key5ddfc576-8de8-45e0-a7e5-721c452e1c9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixtemp C&B
Version Model NumberD60394
Catalog NumberD60394
Company DUNS388000846
Company NameDreve Dentamid 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+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de
Phone+49230388070
Emailinfo@dreve.de

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE239D603941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-20
Device Publish Date2018-06-19

On-Brand Devices [Fixtemp C&B]

E239D503931No.
E239D603991No.
E239D603961No.
E239D603951No.
E239D603941No.
E239D6039351No.
E239D603931No.
E239D6039251No.
E239D603921No.
E239D603911No.

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