Data / Medical devices / Denture Repair Kit
Denture Repair Kit (EBO): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Denture Repair Kit (product code EBO, Class 2, 21 CFR 872.3570). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on July 2, 1985, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EBO
- Device class
- 2
- Regulation
- 872.3570
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 1 |
| India | 1 |
Makers of Denture Repair Kit
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doc Brands, Inc. | Knoxville, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| George Taub Products & Fusion Co., Inc. | Jersey City, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kashmir Surgical Works | AMBALA Haryana, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 1985. 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.