Prosthetic devices · 21 CFR 872 Subpart D
Over the Counter Denture Reliner
FDA device type “Reliner, Denture, Over The Counter”.
- Companies listing it
- 1212 makers
- Brands and models
- 18
- 510(k) clearances
- 30 in five years
- FDA name
- Reliner, Denture, Over The Counter
510(k) clearances per year, 1976–2026
Companies that list EBP
12 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Manufacturera Dental Continental | Mexico | Maker | Edge Liner | 2 | 2001 |
| Sherpa | South Korea | Maker | E&E Extended Working Time Denture Soft Reline Combo Kit · E&E Extended Working Time Denture Soft Reline Kit · E&E Fast Set Pro Denture Soft Reline Kit for Upper & Lower Dentures · E&E Fast Set Pro Denture Soft Reline Kit for Upper and Lower Dentures · +2 | 1 | 2011 |
| Perma Laboratories | United States | Maker | Perma Soft Denture Reliner · ProSoft Denture Reliner | 1 | 2012 |
| one day dental partner | South Korea | Maker | kage reliner, denturem over the counter | — | — |
| Aadi Med Private Limited | India | Maker | Soft Liner | — | — |
| DOC BRANDS, Inc. | United States | Maker | Reline-It · Sof-Grip | — | — |
| Sheffield Pharmaceuticals LLC | United States | Maker | ACRYLINE Denture reliner | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Global Dent Aids Pvt. Ltd. | India | Maker | Sof-Grip | — | — |
| Sonrisa | United States | Maker | Quick Reline | — | — |
| Caribbean Custom Mold Inc | Dominican Republic | Maker | SONRISA/NSI | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 6 Jun 2012 | K121318 | PROSOFT | Perma Laboratories |
| 20 Sep 2010 | K101771 | RELINE-IT MODEL RELINE-IT | Majestic Drug Co., Inc. |
| 10 Aug 1979 | K790589 | DENTURE-TIGHT | Den-Mat Corp. |
Official records: FDA product classification for EBP · 21 CFR 872.3560.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026