Biofit HD Matrix

GUDID D9493180410

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use
Primary Device IDD9493180410
NIH Device Record Keya50a8606-8d79-41c4-a746-2fca05f5a795
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiofit HD Matrix
Version Model Number5.5 mm Premolar
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
HIBCCD9493180410 [Unit of Use]
HIBCCD949318041251 [Primary]
HIBCCD949318041253 [Primary]
HIBCCD949318041501 [Primary]
HIBCCD949318041503 [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 Date2023-09-19
Device Publish Date2023-09-11

On-Brand Devices [Biofit HD Matrix]

D9493180410Clear matrix used in dental restorations.
D9493180310Clear matrix used in dental restorations.
D9493180210Clear matrix used in dental restorations.
D9493180110Clear matrix used in dental restorations.

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