GC OCCLUSAL MATRIX SYSTEM

Basic Information

• Brand Name: GC OCCLUSAL MATRIX SYSTEM
• Primary DI: 10386040009478
• Version / Model: 439154
• Catalog Number: 439154
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-07-13
• Public Version: 1
• Public Version Date: 2022-07-21
• Public Version Status: New
• Public Device Record Key: db4ecc62-539f-477f-bdb6-c055de7f3f55

Device Description

GC OCCLUSAL MATRIX SYSTEM Standard Package, Contains: 25 individual right & left quadrants

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44575	Dental impression spacer	A device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is discarded, thus providing an equidistant space between the oral structures and the impression tray that allows escape of excess impression material and entrapped air, and facilitates manipulation during final impression taking. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00386040009471	GS1
Primary	10386040009478	GS1

Customer Contacts

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