TruContact Kit

GUDID D9498130012

Convenience kit of Bioclear products used in dental restorations.

Bioclear Matrix Systems

Dental abrasive strip, reusable
Primary Device IDD9498130012
NIH Device Record Key4c4a9f30-4a97-456c-9c96-a5add952d64d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruContact Kit
Version Model NumberAssorted
Company DUNS059020838
Company NameBioclear Matrix Systems
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCD9498130012 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


[D9498130012]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-18
Device Publish Date2023-09-10

Devices Manufactured by Bioclear Matrix Systems

D9498271612 - Evolve All-in-One Select Kit2024-10-30 Convenience kit of Bioclear products used in posterior dental restorations.
D9499000412 - BT, Evolve, & DW2024-08-28 Samples of Bioclear products used in dental restorations.
D9498270912 - Evolve Matrix Procedure Kit2024-07-18 Convenience kit of Bioclear products used in posterior dental restorations.
D9495000821 - Bioclear Instrument2024-04-15 Metal instrument used in dental restorations.
D9498271312 - Select Bioclear Evolve Posterior Kit2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations.
D9498271412 - Bioclear Evolve Posterior Kit2024-04-15 Convenience kit of Bioclear products used in posterior dental restorations.
D949208011R1 - Bioclear TwinRing2023-09-25 Separator ring used in dental restorations.
D949208021R1 - Bioclear TwinRing2023-09-25 Separator ring used in dental restorations.

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