Composite Paste (Germany) 0551-GER

GUDID E2350551GER0

Contains DI: E2350551GER0

SHOFU DENTAL CORPORATION

Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice
Primary Device IDE2350551GER0
NIH Device Record Key9db06f53-701f-4d75-87c8-9c78a4a4a752
Commercial Distribution StatusIn Commercial Distribution
Brand NameComposite Paste (Germany)
Version Model Number001
Catalog Number0551-GER
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com
Phone+1(760) 736-3277
Emailcustomer-service@shofu.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE2350551GER0 [Primary]

FDA Product Code

EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


[E2350551GER0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-29
Device Publish Date2022-09-21

Devices Manufactured by SHOFU DENTAL CORPORATION

E235P08111 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-1 5pcs
E235P08121 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-2 5pcs
E235P08131 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-A1 5pcs
E235P08141 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-A2 5pcs
E235P08151 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-BL3 5pcs
E235P08161 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-BL4 5pcs
E235P08201 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g HT-A1 5pcs
E235P08211 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g HT-A2 5pcs

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.