EXAFAST™ 137207

GUDID 20386040005385

EXAFAST™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 20386040005385
• NIH Device Record Key: 6e1f829f-b221-46dd-a2ca-e7c8dba9126a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXAFAST™
• Version Model Number: 137207
• Catalog Number: 137207
• 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

Device Dimensions

• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040005388 [Primary]
GS1	20386040005385 [Package]; Contains: 10386040005388; Package: Carton [16 Units]; In Commercial Distribution

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 [EXAFAST™]

• 10386040005494: EXAFAST™ NDS Super Value Heavy Body Promo Package (20 x 48mL cartridges Heavy (yellow) 90 x mi
• 10386040005487: EXAFAST™ NDS Heavy (yellow) 80-Packs (80 x 48mL cartridges)
• 10386040005470: EXAFAST™ NDS Monophase (purple) 80-Packs (80 x 48mL cartridges)
• 10386040005463: EXAFAST™ NDS Regular (blue) 80-Packs (80 x 48mL cartridges)
• 10386040005456: EXAFAST™ NDS Injection (copper) 80-Packs (80 x 48mL cartridges)
• 20386040005408: EXAFAST™ NDS Heavy (yellow) 75mL Package (2 x 75mL cartridges and 9 x mixing tips)
• 20386040005385: EXAFAST™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 10386040005357: EXAFAST™ NDS Intro Package (2 x 48mL cartridges Injection (copper) and 6 x mixing tips, 4 x 48
• 20386040005323: EXAFAST™ NDS Injection (copper) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 10386040005258: EXAFAST™ NDS Monophase (purple) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005241: EXAFAST™ NDS Regular (blue) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005234: EXAFAST™ NDS Injection (copper) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005210: EXAFAST™NDS Heavy (yellow) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 20386040005187: EXAFAST™ NDS Regular (blue) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 10386040001496: EXAFAST™ Putty 5-5 Pack (5 x 500g blue base Jar & 5 x 500g yellow catalyst Jar)
• 20386040000670: EXAFAST™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 10386040000659: EXAFAST™ Putty 1-1 Pack (1 x 500g blue base Jar & 1 x 500g yellow catalyst Jar)