Identity
- Trade Name
- ProSoft Professional Denture Reliner FDA UDI
- Generic Name
- Denture reliner, soft, home-use FDA UDI
- Device Name
- A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused. FDA UDI
- Model / Reference
- 2ps FDA UDI
- Description
- A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852305002018 FDA UDI
- 510(k) Number
- K121318 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture reliner, soft, home-use
ProSoft Professional Denture Reliner by Perma Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, soft, home-use.
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- JUSTI DENTURE — AMERICAN TOOTH INDUSTRIES · Class II
- DenSureFit — OTC DENTAL · Class II
- DenSureFit Pro — OTC DENTAL · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Perma Laboratories
Sources (1)
- FDA UDI 698f4e6c-43b2-4bf0-a337-f1bda560f0ad 35 fields · synced May 31, 2026