Identity
- Trade Name
- Reline-it FDA UDI
- Generic Name
- Denture reliner, soft, home-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372494101960 FDA UDI
- FDA Product Code
- EBP FDA UDI
- GMDN Term
- Denture reliner, soft, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3560 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 reliner, soft, home-use
Reline-it by Doc Brands, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, soft, home-use.
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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 64adc820-430c-4a4c-9e7c-3c4409f88062 34 fields · synced Jun 1, 2026