Composi-Tight 3D Fusion Matrix System

Basic Information

• Brand Name: Composi-Tight 3D Fusion Matrix System
• Primary DI: 00810038090467
• Version / Model: FX-HHF-00-VM
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• Labeler DUNS: 057647005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 1
• Public Version Date: 2022-10-10
• Public Version Status: New
• Public Device Record Key: 74ed1c45-280b-4a62-bfb1-fc34b4e3be68

Device Description

1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Firm bands (20ea FXH100, 5ea FXH150, 20ea FXH175, 20ea FXH200, 5ea FXH300), 80 Fusion wedges (20 each), 1 FXP01, 4 Varistrips, 5 Margin Elevation bands

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEP	Retainer, Matrix	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62764	Dental matrix band kit	A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810038090467	GS1