EXAlence™ 150004

GUDID 00386040006081

EXA’lence™ Dynamic Mixing Tips, 370mL (50 x mixing tips)

Gc America Inc.

Dental impression tray, single-use
Primary Device ID00386040006081
NIH Device Record Keyb9307de0-930a-474a-8878-bafbcfbe0b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXAlence™
Version Model Number150004
Catalog Number150004
Company DUNS005473608
Company NameGc America Inc.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100386040006081 [Unit of Use]
GS110386040006088 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

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 [EXAlence™]

D6581378651EXA’lence™ 370, Fast Set, 370mL Cartridge Clinic Package, Medium Body (Purple), 6 x cartridg
10386040013406EXA’lence™ REG LIGHT 32 x 48mL BULK W/TIPS
10386040013390EXA’lence™ REG EXTRA LT 32 x 48mL BULK W/TIPS
10386040013383EXA’lence™ REGULAR LIGHT 32 x 48mL BULK PKG
10386040013376EXA’lence™ REG EXTRA LIGHT 32 x 48mL BULK PKG
20386040013366EXA’lence™ Regular Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
20386040013359EXA’lence™ Regular Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing
00386040006265EXA’lence™ Accessories GC Mixing Tips II, 48 x (Yellow)
00386040006197EXA’lence™ Accessories GC Mixing Tips II, 48 x (Aqua)
00386040006128EXA’lence™ Accessories GC Intra-Oral Tips, 100pcs
00386040006098EXA’lence™ Bayonet Locking Rings, 370mL (5 x locking rings)
00386040006081EXA’lence™ Dynamic Mixing Tips, 370mL (50 x mixing tips)
10386040006064Universal VPS Adhesive for EXA Materials 7mL
10386040005838EXA’lence™ FAST 48mL INTRO KIT (Heavy Body /Extra Light Body/Light Body)
10386040005821EXA’lence™ Putty, 500g (278mL) Base Jar, 500g (278mL) Catalyst Jar Standard 1-1 Pack with ac
10386040005814EXA’lence™ REG MONOPHASE 32 x 48mL BULK W/TIPS
10386040005807EXA’lence™ REG HEAVY 32 x 48mL BULK W/TIPS
10386040005791EXA’lence™ FAST MONOPHASE 32 x 48mL BLK W/TIPS
10386040005784EXA’lence™ FAST LIGHT 32 x 48mL BULK W/TIPS
10386040005777EXA’lence™ FAST EXTRA LT 32 x 48mL BULK W/TIPS
10386040005760EXA’lence™ FAST HEAVY 32 x 48mL BULK W/TIPS
10386040005753EXA’lence™ REG MONOPHASE 32 x 48mL BULK PKG
10386040005746EXA’lence™ REGULAR HEAVY 32 x 48mL BULK PKG
10386040005739EXA’lence™ FAST MONOPHASE 32 x 48mL BULK PKG
10386040005722EXA’lence™ FAST LIGHT 32 x 48mL BULK PKG
10386040005715EXA’lence™ FAST EXTRA LIGHT 32 x 48mL BULK PKG
10386040005708EXA’lence™ FAST HEAVY RIGID 32 x 48mL BULK PKG
10386040005692EXA’lence™ FAST HEAVY 32 x 48mL BULK PKG
20386040005583EXA’lence™ Regular Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
20386040005569EXA’lence™ Fast Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
10386040005555EXA’lence™ REG 48mL INTRO KIT (Heavy Body/Extra Light Body/Light Body)
20386040005514EXA’lence™ Fast Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
20386040005361EXA’lence™ Fast Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing ti
20386040005309EXA’lence™ Fast Set 48mL Cartridge Heavy Rigid Body (Green), 4 x cartridges, 12 x mixing tip
20386040005194EXA’lence™ Fast Set 48mL Cartridge Heavy Body (Dark Green), 4 x cartridges, 12 x mixing tips
20386040005170EXA’lence™ Regular Set 48mL Cartridge Heavy Body (Dark Green), 4 x cartridges, 12 x mixing t
20386040006047Universal VPS Adhesive for EXA Materials 7mL (12 pkg)
10386040001762EXA’lence™ 370, Regular Set, 370mL Cartridge Medium Body (Purple), 2 x cartridges
10386040001649EXA’lence™ 370, Regular Set, 370mL Cartridge Heavy Body (Dark Green), 2 x cartridges
10386040001595EXA’lence™ 370, Fast Set, 370mL Cartridge Clinic Package, Heavy Body (Dark Green), 6 x cartr
10386040001588EXA’lence™ 370, Regular Set, 370mL Cartridge Clinic Package, Medium Body (Purple), 6 x cartr
10386040001571EXA’lence™ 370, Regular Set, 370mL Cartridge Clinic Package, Heavy Body (Dark Green), 6 x ca
10386040001526EXA’lence™ 370, Fast Set, 370mL Cartridge Heavy Body (Dark Green), 2 x cartridges
10386040001519EXA’lence™ Putty, 500g (278mL) Base Jar, 500g (278mL) Catalyst Jar Clinic 5-5 Pack with acce
10386040001502EXA’lence™ 370, Fast Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cartrid
10386040001458EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cart
10386040001441EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Medium Body (Purple), 1 x cartrid
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