Bioclear Diamond Wedge

GUDID D949112011501

Plastic wedge used in dental restorations.

Bioclear Matrix Systems

Dental wedge, single-use
Primary Device IDD949112011501
NIH Device Record Key988f4ecb-f891-418e-adc0-a467ca8dd963
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioclear Diamond Wedge
Version Model NumberSmall
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
HIBCCD9491120110 [Unit of Use]
HIBCCD949112011501 [Primary]

FDA Product Code

EJBHandle, Instrument, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-15
Device Publish Date2023-08-07

On-Brand Devices [Bioclear Diamond Wedge]

D9491120510Plastic wedge used in dental restorations.
D9491120410Plastic wedge used in dental restorations.
D9491120310Plastic wedge used in dental restorations.
D9491120210Plastic wedge used in dental restorations.
D949112011501Plastic wedge used in dental restorations.
D9491120110Plastic wedge used in dental restorations.

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