Bioclear Evolve

GUDID D9493272310

Clear matrix used in dental restorations.

Bioclear Matrix Systems

Dental matrix band, single-use
Primary Device IDD9493272310
NIH Device Record Key4ac66a4c-e36d-4615-99ab-71199fa5687b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioclear Evolve
Version Model NumberBlack 7mm
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
HIBCCD9493272310 [Unit of Use]
HIBCCD949327231251 [Primary]
HIBCCD949327231501 [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 Date2023-09-19
Device Publish Date2023-09-11

On-Brand Devices [Bioclear Evolve]

D9493271510Clear matrix used in dental restorations.
D9493271410Clear matrix used in dental restorations.
D9493271310Clear matrix used in dental restorations.
D9493271010Clear matrix used in dental restorations.
D9493270810Clear matrix used in dental restorations.
D9493270710Clear matrix used in dental restorations.
D9493270520Clear matrix used in dental restorations.
D9493270420Clear matrix used in dental restorations.
D9493270320Clear matrix used in dental restorations.
D9493270220Clear matrix used in dental restorations.
D9493270120Clear matrix used in dental restorations.
D9492372610Clear matrix used in dental restorations.
D9493272410Clear matrix used in dental restorations.
D9493272310Clear matrix used in dental restorations.
D9493272210Clear matrix used in dental restorations.
D9493272110Clear matrix used in dental restorations.

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