CARIES DETECTOR

GUDID EKUR000220KA1

Dental caries detecting stain

Primary Device ID	EKUR000220KA1
NIH Device Record Key	f3d1f601-d8f3-4f1d-9efa-5864052c50be
Commercial Distribution Status	In Commercial Distribution
Brand Name	CARIES DETECTOR
Version Model Number	#220-KA
Company DUNS	697119498
Company Name	KURARAY NORITAKE DENTAL INC.
Device Count	2
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	EKUR000220KA0 [Unit of Use]
HIBCC	EKUR000220KA1 [Primary]

LFC	Device, Caries Detection

Steralize Prior To Use	false
Device Is Sterile	false