Roydent 102502R

GUDID D809102502R1

Endodontic filling/sealing material

Primary Device ID	D809102502R1
NIH Device Record Key	1840b72d-811f-4b89-a910-38d351afca01
Commercial Distribution Status	In Commercial Distribution
Brand Name	Roydent
Version Model Number	102502R
Catalog Number	102502R
Company DUNS	131487225
Company Name	ROYDENT DENTAL PRODUCTS INC
Device Count	40
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

Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place

Device Issuing Agency	Device ID
HIBCC	D809102502R0 [Unit of Use]
HIBCC	D809102502R1 [Primary]

KIF	RESIN, ROOT CANAL FILLING

Steralize Prior To Use	false
Device Is Sterile	false