Repair-it

Basic Information

• Brand Name: Repair-it
• Primary DI: 00372494101915
• Version / Model: 1
• Company Name: Doc Brands, Inc.
• Labeler DUNS: 081254601
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-09
• Public Version: 1
• Public Version Date: 2022-03-17
• Public Version Status: New
• Public Device Record Key: f6b778b7-1226-41a5-bc24-4740c91bf708

Device Description

Repair-it is an OTC denture repair kit for home use. The device consists of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks.

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: Yes
• 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
EBO	Denture Repair Kit	Dental	872.3570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31787	Denture repair kit, home-use	A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. 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	00372494101915	GS1

Customer Contacts

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