EXAFLEX® 138401

GUDID 10386040006019

EXAFLEX® Monophase (purple) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 10386040006019
• NIH Device Record Key: b463206a-b558-4475-9a09-7690f3bf657b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXAFLEX®
• Version Model Number: 138401
• Catalog Number: 138401
• 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	10386040006019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955932

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 [EXAFLEX®]

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