Data / Medical devices / External Cleaning Solution
External Cleaning Solution (PME): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make External Cleaning Solution (product code PME, Class 2, 21 CFR 872.3260). 4 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 October 8, 2019, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PME
- Device class
- 2
- Regulation
- 872.3260
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 2 |
| Japan | 1 |
| Turkey | 1 |
| Pakistan | 1 |
Makers of External Cleaning Solution
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 |
|---|---|---|---|---|---|---|---|---|
| Bisco, Inc. | Schaumburg, IL, United States | Manufacturer | 1 | April 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Denali R & D Corporation | Hanover, MA, United States | Complaint file establishment, Specification developer | 1 | December 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| George Taub Products & Fusion Co., Inc. | Jersey City, NJ, United States | Manufacturer | 1 | December 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Kuraray Noritake Dental Niigata Plant | TAINAI Niigata, Japan | Manufacturer | 1 | October 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | Konya, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inter-Med, Inc. | Racine, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liaoning Upcera Co.,Ltd | Benxi Liaoning, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signor Seven International | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viarden Lab LLC | Mission, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 8, 2019. 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.