Data / Medical devices / Reliner, Denture, Over The Counter
Reliner, Denture, Over The Counter (EBP): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Reliner, Denture, Over The Counter (product code EBP, Class 2, 21 CFR 872.3560). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on June 6, 2012, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EBP
- Device class
- 2
- Regulation
- 872.3560
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| India | 2 |
| South Korea | 2 |
| Dominican Republic | 1 |
| Vietnam | 1 |
| Mexico | 1 |
Makers of Reliner, Denture, Over The Counter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Doc Brands, Inc. | Knoxville, TN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | September 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Perma Laboratories | Hinckley, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Aadi Med Private Limited | Dist. Palghar Maharashtra, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caribbean Custom Mold Inc | Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cometech VN Company Limited | Phu Thanh Ward Ho Chi Minh, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Dent Aids Private Limited | NOIDA Uttar Pradesh, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturera Dental Continental | ZAPOPAN Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sherpa Korea | Saha-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheffield Pharmaceuticals LLC | New London, CT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonrisa/Easy Denture/NSI | Wilmington, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 6, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.