EXAMIX™

Basic Information

• Brand Name: EXAMIX™
• Primary DI: 10386040005395
• Version / Model: 137232
• Catalog Number: 137232
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 1
• Public Version Date: 2022-07-15
• Public Version Status: New
• Public Device Record Key: 96409c59-7236-42e1-82d1-6e1eff410ac7

Device Description

EXAMIX™ NDS Heavy (yellow) 32-Packs (32 x 48mL cartridges)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	MATERIAL, IMPRESSION	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10386040005395	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K955932	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: Low: 73 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: Low: 23 Degrees Celsius