LED CURING LIGHT

GUDID 04719873120819

BONART CO., LTD.

Dental laboratory curing unit
Primary Device ID04719873120819
NIH Device Record Keya4c99e44-1c27-4ece-9e48-bf1fcb1bcf40
Commercial Distribution StatusIn Commercial Distribution
Brand NameLED CURING LIGHT
Version Model NumberART-L3 PRO
Company DUNS657263687
Company NameBONART CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS104719873120819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBZActivator, Ultraviolet, For Polymerization

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719873120819]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-19

On-Brand Devices [LED CURING LIGHT]

04719873120819ART-L3 PRO
04719873120802ART-L3

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