Data / Medical devices / United States / Valplast Intl. Corp.
Valplast Intl. Corp.: FDA-registered device maker in E Northport, NY, United States, 1 510(k) clearance
Valplast Intl. Corp. is registered with the FDA (registration 2436918) in E Northport, NY, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 7, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2436918
- FEI number
- 3000720062
- Address
- 35 Doyle Ct Suite 5, E Northport, NY, United States, 11731
- Owner or operator
- VALPLAST INTL. CORP. (9008731)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 4, 1994
- Registered through
- 2026
- Brand names listed
- Denture Sonic, Platinum Line, Precise-Fit, Val-Clean, Valplast, Valplast 110N, Valplast Bur
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cleaner, Denture, Mechanical | JER | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2006 | K060507 | VALPLAST YAMAHACHI TEETH | ELM | Substantially Equivalent | Valplast Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Denture, Mechanical
- All makers of Denture, Plastic, Teeth
- All makers of Cleanser, Denture, Over The Counter
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Bur, Dental
- All makers of Material, Impression Tray, Resin
Updated April 7, 2006. 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.