Composi-Tight 3D Fusion Sectional Matrix System

GUDID 00810038090450

1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fusion bands (20/5/20/20/5), 80 Fusion wedges (20 each), 1 FXP01, 4x Varistrips, 5x Margin Elevation bands

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental matrix band kit

• Primary Device ID: 00810038090450
• NIH Device Record Key: 2a03d10e-f85c-4ebd-9909-038f46849e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Composi-Tight 3D Fusion Sectional Matrix System
• Version Model Number: FX-KFF-00-VM
• Company DUNS: 057647005
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 800-842-2244
• Email: mmorris@garrisondental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038090450 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810038090450]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-10
• Device Publish Date: 2022-09-30

Devices Manufactured by GARRISON DENTAL SOLUTIONS, L.L.C.

• 00810038096490 - Composi-Tight 3D Fusion: 2023-08-29 Composi-Tight 3D Fusion Firm Matrix Bands Sample Kit
• 00810038090207 - Composi-Tight 3D Fusion: 2023-08-28 Composi-Tight 3D Fusion Sectional Matrix Student Kit
• 00810038090931 - Composi-Tight™: 2023-08-21 Composi-Tight™ 3D Fusion Sectional Matrix System Kit
• 00810038090962 - Strata-G™: 2023-08-21 Strata-G™ Matrix Band Trial Kit
• 00810038090979 - Strata-G™: 2023-08-21 Strata-G™ Wedge Trial Kit
• 00810038090948 - Strata-G™: 2023-05-17 Strata-G™ Firm Sectional Matrix System Intro Kit
• 00810038090955 - Strata-G™: 2023-05-17 Strata-G™ Firm Sectional Matrix System Standard Kit
• 00810038090863 - Loop™: 2023-05-01 Loop™ Protective Light Shield