EXAFAST™ 137286

GUDID 10386040005463

EXAFAST™ NDS Regular (blue) 80-Packs (80 x 48mL cartridges)

Gc America Inc.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 10386040005463
• NIH Device Record Key: b0fa40ed-0f67-4bc2-8e2b-e30c5a28b41e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXAFAST™
• Version Model Number: 137286
• Catalog Number: 137286
• 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 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
• Storage Environment Temperature: Between 23 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040005463 [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 [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)