Data / Medical devices / Tester, Pulp
Tester, Pulp (EAT): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Tester, Pulp (product code EAT, Class 2, 21 CFR 872.1720). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on September 6, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EAT
- Device class
- 2
- Regulation
- 872.1720
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| China | 2 |
| South Korea | 1 |
| Mexico | 1 |
Makers of Tester, Pulp
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 |
|---|---|---|---|---|---|---|---|---|
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 4 | June 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Pomona, CA, United States | Specification developer | 2 | April 7, 1997 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | May 9, 1995 | 0 | 0 | 0 | api.fda.gov |
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denjoy Dental Co., Ltd | Changsha city Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecotec Manufacturing | Okeechobee, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stoner Incorporated | Quarryville, PA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 6, 2002. 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.