Fixtemp C&B D60393

GUDID E239D603931

No.

Dreve Dentamid GmbH

Dental crown/bridge resin, temporary
Primary Device IDE239D603931
NIH Device Record Keyf0ea2746-42b1-4235-8095-8844e4baf485
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixtemp C&B
Version Model NumberD60393
Catalog NumberD60393
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
HIBCCE239D603931 [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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