Bifix Temp 1056

GUDID E22110561

Bifix Temp is a dual-curing, composite-based temporary luting material.

VOCO GmbH

Dental composite resin
Primary Device IDE22110561
NIH Device Record Keyd6e648d0-8300-4ff3-bc78-6ea8688f0fe3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBifix Temp
Version Model Number1056
Catalog Number1056
Company DUNS316699578
Company NameVOCO 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

Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22110561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-30
Device Publish Date2025-01-22

On-Brand Devices [Bifix Temp]

E22110551Bifix Temp is a dual-curing, composite-based temporary luting material.
E22110561Bifix Temp is a dual-curing, composite-based temporary luting material.

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