Composi-Tight 3D Fusion Matrix System

GUDID 00810038090467

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

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental matrix band kit
Primary Device ID00810038090467
NIH Device Record Key74ed1c45-280b-4a62-bfb1-fc34b4e3be68
Commercial Distribution StatusIn Commercial Distribution
Brand NameComposi-Tight 3D Fusion Matrix System
Version Model NumberFX-HHF-00-VM
Company DUNS057647005
Company NameGARRISON DENTAL SOLUTIONS, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810038090467 [Primary]

FDA Product Code

JEPRetainer, Matrix

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810038090467]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-10
Device Publish Date2022-09-30

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

00810038096490 - Composi-Tight 3D Fusion2023-08-29 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

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