Novocol EXACTON HARD CHRSD RELINE PWD/LIQ

Basic Information

• Brand Name: Novocol EXACTON HARD CHRSD RELINE PWD/LIQ
• Primary DI: 07540187001450
• Version / Model: FP-NOVOINC-125
• Company Name: SEPTODONT, INC
• Labeler DUNS: 012925513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-08-09
• Public Version Status: Update
• Public Device Record Key: 1c420eb8-b8d9-4285-a915-a2f5eaed8b16

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• 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
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34769	Denture reliner, elastic, short-term	A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540187001450	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]