Bioclear TwinRing Molar/Premolar Pack

GUDID D949208031K1

Separator ring used in dental restorations.

Bioclear Matrix Systems

Dental matrix band retainer
Primary Device IDD949208031K1
NIH Device Record Key7cdbaa50-8ff3-4888-8258-5cb7301ba133
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioclear TwinRing Molar/Premolar Pack
Version Model NumberMolar/Premolar Pack
Company DUNS059020838
Company NameBioclear Matrix Systems
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 Usefalse
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
HIBCCD949208031K1 [Primary]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


[D949208031K1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-16

On-Brand Devices [Bioclear TwinRing Molar/Premolar Pack]

D949208031K1Separator ring used in dental restorations.
D9492080311Separator ring used in dental restorations.

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