Repair-It

GUDID 20010705400917

Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and mend cracks.

MAJESTIC DRUG CO. INC.

Denture repair kit, home-use

• Primary Device ID: 20010705400917
• NIH Device Record Key: f16881eb-9b42-40d3-bfbc-298ca91a4738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Repair-It
• Version Model Number: 1
• Company DUNS: 001496777
• Company Name: MAJESTIC DRUG CO. INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00010705400913 [Primary]
GS1	20010705400917 [Package]; Contains: 70010705400912; Package: Case [16 Units]; In Commercial Distribution
GS1	30010705400914 [Package]; Contains: 70010705400912; Package: Case [16 Units]; In Commercial Distribution
GS1	70010705400912 [Package]; Contains: 00010705400913; Package: Pack [6 Units]; In Commercial Distribution

FDA Product Code

• EBO: Over The Counter Denture Repair Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-11-06
• Device Publish Date: 2016-07-27

Devices Manufactured by MAJESTIC DRUG CO. INC.

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