Data / Medical devices / United States / Harvest Dental Products LLC
Harvest Dental Products LLC: FDA-registered device maker in Brea, CA, United States, 3 510(k) clearances
Harvest Dental Products LLC is registered with the FDA (registration 3008578884) in Brea, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008578884
- Address
- 905 Columbia St., Brea, CA, United States, 92821
- Owner or operator
- Harvest Dental Products, LLC (10041217)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 26, 2013
- Registered through
- 2026
- Brand names listed
- EasyGum Composite Strip, Poly Cast, PolyGum, PolySplint, Temp Esthetic, Temp Fix, ZCAD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | 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 |
|---|---|---|---|---|---|---|
| August 16, 2023 | K231389 | Harvest Dental HD Gum Strip | EBI | Substantially Equivalent | Harvest Dental Products, LLC | accessdata.fda.gov |
| August 11, 2011 | K110719 | ORIGIN ZIRCONIA | EIH | Substantially Equivalent | B&D Dental Technologies | accessdata.fda.gov |
| December 16, 2010 | K102341 | VIPI BLOCK | EBG | Substantially Equivalent | Vipi Industria,Comercio,Exportacao E Importacao DE | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Powder, Porcelain
- All makers of Material, Tooth Shade, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated August 16, 2023. 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.