Black Triangle (BT) Kit

GUDID D9498010162

Convenience kit of Bioclear products used in anterior dental restorations.

Bioclear Matrix Systems

Dental implantation depth/angle gauge, reusable
Primary Device IDD9498010162
NIH Device Record Keyda77fd47-1173-4b45-9ad4-8f9b98e93257
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlack Triangle (BT) Kit
Version Model NumberStudent/EM
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 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
HIBCCD9498010162 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-11
Device Publish Date2024-12-03

Devices Manufactured by Bioclear Matrix Systems

D9498010162 - Black Triangle (BT) Kit2024-12-11Convenience kit of Bioclear products used in anterior dental restorations.
D9498010162 - Black Triangle (BT) Kit2024-12-11 Convenience kit of Bioclear products used in anterior dental restorations.
D9498271712 - Evolve All-in-One Select Kit2024-12-11 Convenience kit of Bioclear products used in posterior dental restorations.
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.

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