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
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
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
JEP
Product Code Name
Retainer, Matrix
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 436 |