Roydent 765

GUDID D8097651

Dental prosthesis dye

Primary Device ID	D8097651
NIH Device Record Key	456f2096-5f7c-4e3c-9f6d-83247dbf909b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Roydent
Version Model Number	765
Catalog Number	765
Company DUNS	131487225
Company Name	ROYDENT DENTAL PRODUCTS INC
Device Count	150
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	true
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

Total Volume	0.3 Milliliter
Total Volume	0.3 Milliliter

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	D8097650 [Unit of Use]
HIBCC	D8097651 [Primary]

LFC	DEVICE, CARIES DETECTION

Steralize Prior To Use	false
Device Is Sterile	false