Original Posterior Matrix B Series

GUDID D949303021B0

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use
Primary Device IDD949303021B0
NIH Device Record Key80aab151-a590-4ff3-8cdb-3267239a7037
Commercial Distribution StatusIn Commercial Distribution
Brand NameOriginal Posterior Matrix B Series
Version Model NumberB302 Blue
Company DUNS059020838
Company NameBioclear Matrix Systems
Device Count50
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD94930302125B1 [Primary]
HIBCCD94930302150B1 [Primary]
HIBCCD949303021B0 [Unit of Use]

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 Date2023-09-19
Device Publish Date2023-09-11

On-Brand Devices [Original Posterior Matrix B Series]

D949303031C0Clear matrix used in dental restorations.
D949303031B0Clear matrix used in dental restorations.
D949303021C0Clear matrix used in dental restorations.
D949303021B0Clear matrix used in dental restorations.
D949303011C0Clear matrix used in dental restorations.
D949303011B0Clear matrix used in dental restorations.

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