LUMINDEX

GUDID 04719873921782

LUMINDEX 3 (Dentmate-Plaque)

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 ID	04719873921782
NIH Device Record Key	e23b9cb0-88d7-420c-93f9-47036a02f4b3
Commercial Distribution Status	In Commercial Distribution
Brand Name	LUMINDEX
Version Model Number	LUMINDEX 3
Company DUNS	656134660
Company Name	DENTMATE TECHNOLOGY CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873921782 [Primary]

FDA Product Code

HJN	Transilluminator, Battery-Powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2023-08-03
Device Publish Date	2019-07-17

On-Brand Devices [LUMINDEX]

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