Structur CAD 6079

GUDID E22160790

bloc 1 x 40L A3 bloc 1 x 40L A2

VOCO GmbH

Dental crown/bridge, temporary
Primary Device IDE22160790
NIH Device Record Key88104a7d-d5e1-4ed2-ae23-7e0bd5428dbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameStructur CAD
Version Model Number6079
Catalog Number6079
Company DUNS316699578
Company NameVOCO GmbH
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
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
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
HIBCCE22160790 [Unit of Use]
HIBCCE22160791 [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 Date2020-09-22
Device Publish Date2020-09-14

On-Brand Devices [Structur CAD]

E22160790bloc 1 x 40L A3 bloc 1 x 40L A2
E22160780blocs 5 x 40L A3
E22160770blocs 5 x 40L A2
E22160760blocs 5 x 40L A1
E22160731Disc A3 20 mm
E22160721Disc A2 20 mm
E22160711Disc A1 20 mm

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