Denovo Preformed Matrix strip

GUDID 00810059290969

Denovo Preformed Matrix Band - Pediatric 3/16, Anterior

Denovo Dental, Inc.

Dental matrix band, reusable
Primary Device ID00810059290969
NIH Device Record Keye3d6267b-92ef-4390-8589-596b4cee0029
Commercial Distribution StatusIn Commercial Distribution
Brand NameDenovo Preformed Matrix strip
Version Model Number170-315L
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 Kitfalse
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
GS100810059290969 [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 strip]

00810059291126Denovo Preformed Matrix Band - Adult 1/4, Anterior
00810059290969Denovo Preformed Matrix Band - Pediatric 3/16, Anterior

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.