Identity
- Trade Name
- Repair-it FDA UDI
- Generic Name
- Denture repair kit, home-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372494101915 FDA UDI
- FDA Product Code
- EBO FDA UDI
- GMDN Term
- Denture repair kit, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture repair kit, home-use
Repair-it by Doc Brands, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture repair kit, home-use.
- Repair-It — Majestic Drug Co., Inc. · Class II
- PERK Emergency Denture Repair Kit — PERMA LABORATORIES · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Doc Brands, Inc.
Sources (1)
- FDA UDI f6b778b7-1226-41a5-bc24-4740c91bf708 34 fields · synced Jun 6, 2026