Composi-Tight 3D Fusion Matrix System - 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Firm - GARRISON DENTAL SOLUTIONS, L.L.C.

Duns Number:057647005

Device Description: 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Firm bands (20ea FXH100, 5ea FXH150, 20ea FXH 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

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More Product Details

Catalog Number

-

Brand Name

Composi-Tight 3D Fusion Matrix System

Version/Model Number

FX-HHF-00-VM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JEP

Product Code Name

Retainer, Matrix

Device Record Status

Public Device Record Key

74ed1c45-280b-4a62-bfb1-fc34b4e3be68

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GARRISON DENTAL SOLUTIONS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 436