EXAFLEX® 138020

GUDID 10386040005845

EXAFLEX® Regular (blue) Clinic Packs (20 x 74mL base, 20 x 74mL catalyst)

Gc America Inc.

Silicone dental impression material
Primary Device ID10386040005845
NIH Device Record Key8b067f94-9d79-4c04-8124-aa5cac03b4bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXAFLEX®
Version Model Number138020
Catalog Number138020
Company DUNS005473608
Company NameGc America Inc.
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+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110386040005845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-15
Device Publish Date2022-07-07

On-Brand Devices [EXAFLEX®]

10386040006040EXAFLEX® Regular (blue) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
20386040006016EXAFLEX® Monophase (purple) Clinic Packs (20 x 74mL base, 20 x 74mL catalyst)
10386040006019EXAFLEX® Monophase (purple) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
10386040005982EXAFLEX® Catalyst (One pail 30 kg)
10386040005975EXAFLEX® Base (One pail 30kg)
20386040005934EXAFLEX® 5-5 Pack (5 x 500g blue base Jar, 5 x 500g yellow catalyst Jar, 10 x scoops)
10386040005937EXAFLEX® Putty 1-1 Pack (1 x 500g blue base Jar, 1 x 500g yellow catalyst Jar, 2 x scoops)
20386040005910EXAFLEX® Heavy (yellow) Clinic Packs (20 x 74mL base, 20 x 74mL catalyst)
10386040005913EXAFLEX® Heavy (yellow) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
20386040005873EXAFLEX® Injection (pink) Clinic Packs (20 x 74mL base, 20 x 74mL catalyst)
10386040005876EXAFLEX® Injection (pink) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
10386040005845EXAFLEX® Regular (blue) Clinic Packs (20 x 74mL base, 20 x 74mL catalyst)

Trademark Results [EXAFLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXAFLEX
EXAFLEX
90774341 not registered Live/Pending
Truegenics Pte. Ltd.
2021-06-15
EXAFLEX
EXAFLEX
73245051 1163378 Live/Registered
G-C Dental Industrial Corp.
1980-01-03

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