COE TRAY PLASTIC™ 240093

GUDID D6582400931

COE TRAY PLASTIC™ Regular Set Liquid can 1 quart (946 mL)

Gc America Inc.

Dental impression spacer
Primary Device IDD6582400931
NIH Device Record Key0ba0bf13-f776-442b-b504-b641e420bd99
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOE TRAY PLASTIC™
Version Model Number240093
Catalog Number240093
Company DUNS005473608
Company NameGc America Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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

Device Dimensions

Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter
Total Volume946 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 21 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6582400931 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-01-21
Device Publish Date2017-02-10

On-Brand Devices [COE TRAY PLASTIC™]

D6582401941COE TRAY PLASTIC™ Fast Set Liquid 1 gallon (4 1-qt. cans)
10386040006460COE TRAY PLASTIC™ Fast Set Liquid Can 1 Quart (946mL)
10386040006453COE TRAY PLASTIC™ Fast Set Liquid Can 1 Pint (473mL)
10386040006446COE TRAY PLASTIC™ Fast Set Liquid bottle 6 oz. (117mL)
10386040006439COE TRAY PLASTIC™ Fast Set-White Economy Package, powder 3 lbs. (1.4kg), liquid 1 pt. (473mL),
10386040006422COE TRAY PLASTIC™ Professional Package, Fast Set White powder 1 lb. (454g), Liquid 6 oz. (177m
10386040006408COE TRAY PLASTIC™ Regular Set Liquid can 1 quart (946 mL)
10386040006392COE TRAY PLASTIC™ Liquid can 1 pint (473mL)
10386040006385COE TRAY PLASTIC™ Liquid bottle 6 oz. (117mL)
10386040006378COE TRAY PLASTIC™ Powder Drum 25 lb. White
10386040006361COE TRAY PLASTIC™ Powder Jar 3 lb. (1.4 kg)
10386040006354COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-
10386040006347COE TRAY PLASTIC™ Powder Jar 1 lb. (454g)
10386040006330COE TRAY PLASTIC™ Professional Package, Regular Set White, powder 1 lb (454g), liquid 6 oz.
D6582401931COE TRAY PLASTIC™ Fast Set Liquid Can 1 Quart (946mL)
D6582401921COE TRAY PLASTIC™ Fast Set Liquid Can 1 Pint (473mL)
D6582401911COE TRAY PLASTIC™ Fast Set Liquid bottle 6 oz. (117mL)
D6582401131COE TRAY PLASTIC™ Fast Set-White Economy Package, powder 3 lbs. (1.4kg), liquid 1 pt. (473mL),
D6582401111COE TRAY PLASTIC™ Professional Package, Fast Set White powder 1 lb. (454g), Liquid 6 oz. (177m
D6582400931COE TRAY PLASTIC™ Regular Set Liquid can 1 quart (946 mL)
D6582400921COE TRAY PLASTIC™ Liquid can 1 pint (473mL)
D6582400911COE TRAY PLASTIC™ Liquid bottle 6 oz. (117mL)
D6582400161COE TRAY PLASTIC™ Powder Drum 25 lb. White
D6582400141COE TRAY PLASTIC™ Powder Jar 3 lb. (1.4 kg)
D6582400131COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-
D6582400121COE TRAY PLASTIC™ Powder Jar 1 lb. (454g)
D6582400111COE TRAY PLASTIC™ Professional Package, Regular Set White, powder 1 lb (454g), liquid 6 oz.

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