Reline-It

Basic Information

• Brand Name: Reline-It
• Primary DI: 00010705400968
• Version / Model: 1
• Company Name: MAJESTIC DRUG CO. INC.
• Labeler DUNS: 001496777
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-27
• Public Version: 5
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 2ab93125-ecc2-469b-9145-e38134917bd3

Device Description

The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBP	Reliner, Denture, Over The Counter	Dental	872.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31788	Denture reliner, soft, home-use	A denture relining material such as plastic resin intended to be self-applied at home as a permanent coating or lining on the base or tissue-contact surface of a denture for improved fitting, and which sets to a soft, plastic state. It will enable the user to make a permanent adjustment without professional assistance. 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	00010705400968	GS1
Package	50010705400963	GS1	Tray	6	In Commercial Distribution
Package	30010705400969	GS1	Case	16	In Commercial Distribution
Package	40010705400966	GS1	Pack	6	In Commercial Distribution
Package	20010705400962	GS1	Case	16	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101771	000