Home GUDID H668166211 Cora-Caine
Primary DI H668166211
Brand Cora-Caine
Company Keystone Industries
Model 16621
Catalog number 16621
Device description CORA-CAINE Denture Adhesive (36-4g)
Published 2022-11-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KOP ADHESIVE, DENTURE, KARAYA
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KOP Adhesive, Denture, Karaya Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status H668166211 Primary HIBCC 0 H668166210 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Karaya denture adhesive An adhesive compound composed of karaya (a fine vegetable gum powder) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from moisture Special Storage Condition, Specify 0 0 Keep out of direct sunlight
Regulatory Flags# DUNS number 073503117 Device count 36 Premarket exempt true Combination product true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published H668166210 Cora-Caine Keystone Industries KOP 2022-11-30
keystoneind.com