Bioclear Instrument

GUDID D9495000213

Metal instrument used in dental restorations.

Bioclear Matrix Systems

Dental restoration carver, multiple-material
Primary Device IDD9495000213
NIH Device Record Keyca1bbd49-4a7f-46bf-a100-6a79eae3c667
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioclear Instrument
Version Model NumberSculpting Point
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 Kitfalse
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
HIBCCD9495000213 [Primary]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


[D9495000213]

Moist Heat or Steam Sterilization


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 [Bioclear Instrument]

D9495001311Metal instrument used in dental restorations.
D9495001221Plastic instrument used in dental restorations.
D9495001111Plastic instrument used in dental restorations.
D9495001110Plastic instrument used in dental restorations.
D9495000811Metal instrument used in dental restorations.
D9495000711Metal instrument used in dental restorations.
D9495000611Metal instrument used in dental restorations.
D9495000511Metal instrument used in dental restorations.
D9495000411Metal instrument used in dental restorations.
D9495000311Metal instrument used in dental restorations.
D9495000211Metal instrument used in dental restorations.
D9495000111Metal instrument used in dental restorations.
D9495001313Metal instrument used in dental restorations.
D9495001223Plastic instrument used in dental restorations.
D9495001113Plastic instrument used in dental restorations.
D9495000813Metal instrument used in dental restorations.
D9495000613Metal instrument used in dental restorations.
D9495000413Metal instrument used in dental restorations.
D9495000313Metal instrument used in dental restorations.
D9495000213Metal instrument used in dental restorations.
D9495000113Metal instrument used in dental restorations.
D9495000821Metal instrument used in dental restorations.

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