HD Anterior Matrix A Series

GUDID D9493200110

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use
Primary Device IDD9493200110
NIH Device Record Keyb6756f32-dc1e-4a4c-bb55-538a6ca6ee48
Commercial Distribution StatusIn Commercial Distribution
Brand NameHD Anterior Matrix A Series
Version Model NumberA101 HD
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
HIBCCD9493200110 [Unit of Use]
HIBCCD949320011101 [Primary]
HIBCCD949320011151 [Primary]
HIBCCD949320011251 [Primary]
HIBCCD949320011253 [Primary]
HIBCCD949320011501 [Primary]
HIBCCD949320011503 [Primary]

FDA Product Code

JEPRetainer, Matrix

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

On-Brand Devices [HD Anterior Matrix A Series]

D9493200510Clear matrix used in dental restorations.
D9493200410Clear matrix used in dental restorations.
D9493200310Clear matrix used in dental restorations.
D9493200210Clear matrix used in dental restorations.
D9493200110Clear matrix used in dental restorations.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.