Cora-Caine

Basic Information

• Brand Name: Cora-Caine
• Primary DI: H668166211
• Version / Model: 16621
• Catalog Number: 16621
• Company Name: Keystone Industries
• Labeler DUNS: 073503117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 8effa076-711a-4f40-a5e8-d8987f994602

Device Description

CORA-CAINE Denture Adhesive (36-4g)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOP	ADHESIVE, DENTURE, KARAYA	Dental	872.3450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46128	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	H668166210	HIBCC
Primary	H668166211	HIBCC

Customer Contacts

• Phone: [phone] ext. 8455
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from moisture
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight