Denovo Preformed Matrix Bands Kit

GUDID 00810059291164

Denovo Preformed Matrix Band Kit - Adult 1/4 Professional

Denovo Dental, Inc.

Dental matrix band, reusable
Primary Device ID00810059291164
NIH Device Record Key787ede15-a242-418e-9b07-9e64ad145f25
Commercial Distribution StatusIn Commercial Distribution
Brand NameDenovo Preformed Matrix Bands Kit
Version Model Number171-600
Company DUNS183498179
Company NameDenovo Dental, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810059291164 [Primary]

FDA Product Code

JEPRetainer, Matrix

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-10
Device Publish Date2023-06-30

On-Brand Devices [Denovo Preformed Matrix Bands Kit]

00810059291140Denovo Preformed Matrix Band Kit - Pediatric 3/16 Professional
00810059291133Denovo Preformed Matrix Band Kit - Pediatric 3/16 Introductory
00810059291164Denovo Preformed Matrix Band Kit - Adult 1/4 Professional
00810059291157Denovo Preformed Matrix Band Kit - Adult 1/4 Introductory

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