Composi-Tight®

Basic Information

• Brand Name: Composi-Tight®
• Primary DI: 20810038092809
• Version / Model: FXH150
• Catalog Number: FXH150
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• Labeler DUNS: 057647005
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 1
• Public Version Date: 2020-05-04
• Public Version Status: New
• Public Device Record Key: 6d39c6b4-f2e5-44bb-b313-77fa66976d6a

Device Description

3D Fusion™ Firm Matrix Band with Extension, Bicuspid

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. 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	00810038092805	GS1
Primary	20810038092809	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Extended Height 5.9 Millimeter