EXAlence™ 137718

GUDID 10386040013406

EXA’lence™ REG LIGHT 32 x 48mL BULK W/TIPS

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 10386040013406
• NIH Device Record Key: 273ba34b-c488-4fec-90d8-7fff351de7bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXAlence™
• Version Model Number: 137718
• Catalog Number: 137718
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040013406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041398

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [EXAlence™]

• D6581378651: EXA’lence™ 370, Fast Set, 370mL Cartridge Clinic Package, Medium Body (Purple), 6 x cartridg
• 10386040013406: EXA’lence™ REG LIGHT 32 x 48mL BULK W/TIPS
• 10386040013390: EXA’lence™ REG EXTRA LT 32 x 48mL BULK W/TIPS
• 10386040013383: EXA’lence™ REGULAR LIGHT 32 x 48mL BULK PKG
• 10386040013376: EXA’lence™ REG EXTRA LIGHT 32 x 48mL BULK PKG
• 20386040013366: EXA’lence™ Regular Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
• 20386040013359: EXA’lence™ Regular Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing
• 00386040006265: EXA’lence™ Accessories GC Mixing Tips II, 48 x (Yellow)
• 00386040006197: EXA’lence™ Accessories GC Mixing Tips II, 48 x (Aqua)
• 00386040006128: EXA’lence™ Accessories GC Intra-Oral Tips, 100pcs
• 00386040006098: EXA’lence™ Bayonet Locking Rings, 370mL (5 x locking rings)
• 00386040006081: EXA’lence™ Dynamic Mixing Tips, 370mL (50 x mixing tips)
• 10386040006064: Universal VPS Adhesive for EXA Materials 7mL
• 10386040005838: EXA’lence™ FAST 48mL INTRO KIT (Heavy Body /Extra Light Body/Light Body)
• 10386040005821: EXA’lence™ Putty, 500g (278mL) Base Jar, 500g (278mL) Catalyst Jar Standard 1-1 Pack with ac
• 10386040005814: EXA’lence™ REG MONOPHASE 32 x 48mL BULK W/TIPS
• 10386040005807: EXA’lence™ REG HEAVY 32 x 48mL BULK W/TIPS
• 10386040005791: EXA’lence™ FAST MONOPHASE 32 x 48mL BLK W/TIPS
• 10386040005784: EXA’lence™ FAST LIGHT 32 x 48mL BULK W/TIPS
• 10386040005777: EXA’lence™ FAST EXTRA LT 32 x 48mL BULK W/TIPS
• 10386040005760: EXA’lence™ FAST HEAVY 32 x 48mL BULK W/TIPS
• 10386040005753: EXA’lence™ REG MONOPHASE 32 x 48mL BULK PKG
• 10386040005746: EXA’lence™ REGULAR HEAVY 32 x 48mL BULK PKG
• 10386040005739: EXA’lence™ FAST MONOPHASE 32 x 48mL BULK PKG
• 10386040005722: EXA’lence™ FAST LIGHT 32 x 48mL BULK PKG
• 10386040005715: EXA’lence™ FAST EXTRA LIGHT 32 x 48mL BULK PKG
• 10386040005708: EXA’lence™ FAST HEAVY RIGID 32 x 48mL BULK PKG
• 10386040005692: EXA’lence™ FAST HEAVY 32 x 48mL BULK PKG
• 20386040005583: EXA’lence™ Regular Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
• 20386040005569: EXA’lence™ Fast Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
• 10386040005555: EXA’lence™ REG 48mL INTRO KIT (Heavy Body/Extra Light Body/Light Body)
• 20386040005514: EXA’lence™ Fast Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
• 20386040005361: EXA’lence™ Fast Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing ti
• 20386040005309: EXA’lence™ Fast Set 48mL Cartridge Heavy Rigid Body (Green), 4 x cartridges, 12 x mixing tip
• 20386040005194: EXA’lence™ Fast Set 48mL Cartridge Heavy Body (Dark Green), 4 x cartridges, 12 x mixing tips
• 20386040005170: EXA’lence™ Regular Set 48mL Cartridge Heavy Body (Dark Green), 4 x cartridges, 12 x mixing t
• 20386040006047: Universal VPS Adhesive for EXA Materials 7mL (12 pkg)
• 10386040001762: EXA’lence™ 370, Regular Set, 370mL Cartridge Medium Body (Purple), 2 x cartridges
• 10386040001649: EXA’lence™ 370, Regular Set, 370mL Cartridge Heavy Body (Dark Green), 2 x cartridges
• 10386040001595: EXA’lence™ 370, Fast Set, 370mL Cartridge Clinic Package, Heavy Body (Dark Green), 6 x cartr
• 10386040001588: EXA’lence™ 370, Regular Set, 370mL Cartridge Clinic Package, Medium Body (Purple), 6 x cartr
• 10386040001571: EXA’lence™ 370, Regular Set, 370mL Cartridge Clinic Package, Heavy Body (Dark Green), 6 x ca
• 10386040001526: EXA’lence™ 370, Fast Set, 370mL Cartridge Heavy Body (Dark Green), 2 x cartridges
• 10386040001519: EXA’lence™ Putty, 500g (278mL) Base Jar, 500g (278mL) Catalyst Jar Clinic 5-5 Pack with acce
• 10386040001502: EXA’lence™ 370, Fast Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cartrid
• 10386040001458: EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Heavy Body (Dark Green), 1 x cart
• 10386040001441: EXA’lence™ 370, Regular Set, 370mL Cartridge Standard Kit, Medium Body (Purple), 1 x cartrid