Reline-It

GUDID 00010705400968

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.

MAJESTIC DRUG CO. INC.

Denture reliner, soft, home-use

• Primary Device ID: 00010705400968
• NIH Device Record Key: 2ab93125-ecc2-469b-9145-e38134917bd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reline-It
• Version Model Number: 1
• Company DUNS: 001496777
• Company Name: MAJESTIC DRUG CO. INC.
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com
• Phone: 800-238-0220
• Email: custserv@majesticdrug.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00010705400968 [Primary]
GS1	20010705400962 [Package]; Contains: 40010705400966; Package: Case [16 Units]; In Commercial Distribution
GS1	30010705400969 [Package]; Contains: 50010705400963; Package: Case [16 Units]; In Commercial Distribution
GS1	40010705400966 [Package]; Package: Pack [6 Units]; In Commercial Distribution
GS1	50010705400963 [Package]; Package: Tray [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101771

FDA Product Code

• EBP: Reliner, Denture, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-11-06
• Device Publish Date: 2016-07-27

Devices Manufactured by MAJESTIC DRUG CO. INC.

• 20010705400917 - Repair-It: 2020-11-06 Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and
• 00010705400968 - Reline-It: 2020-11-06The 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.
• 00010705400968 - Reline-It: 2020-11-06 The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder w