LUMINDEX

GUDID 04719873921775

LUMINDEX 3 (Dentmate)

DENTMATE TECHNOLOGY CO., LTD.

Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator Visible-light skin transilluminator
Primary Device ID04719873921775
NIH Device Record Key3951aed2-bdb4-40c0-b1ad-891eba6ce94f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUMINDEX
Version Model NumberLUMINDEX 3
Company DUNS656134660
Company NameDENTMATE TECHNOLOGY CO., LTD.
Device Count1
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873921775 [Primary]

FDA Product Code

HJNTransilluminator, Battery-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-03
Device Publish Date2019-07-17

On-Brand Devices [LUMINDEX]

04719873921461LUMINDEX 5 (US)
04719873921782LUMINDEX 3 (Dentmate-Plaque)
04719873921775LUMINDEX 3 (Dentmate)
04719873921447LUMINDEX 3 (Practicon)
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