Composi-TIght

GUDID 00810038090405

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental matrix band kit

• Primary Device ID: 00810038090405
• NIH Device Record Key: c5c821de-3203-407b-b7ba-dc48c3f6c0d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Composi-TIght
• Version Model Number: CE-M01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038090405 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-01

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