Harvest Dental Products LLC
Brea, CA, US
HARVEST DENTAL PRODUCTS LLC appears in FDA device records in Brea, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Harvest Dental Products LLC between 2014 and 2023. The busiest year on record is 2023, with 3. The most recent is 2023, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2018 | 1 |
| 2023 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231389 | Harvest Dental HD Gum Strip | EBI | Substantially Equivalent | |
| K222961 | Harvest Conceal ZR Block Out | EIH | Substantially Equivalent | |
| K222489 | Harvest Printable Resin | EBI | Substantially Equivalent | |
| K180578 | Harvest Dental Polymer Blocks | EBG | Substantially Equivalent | |
| K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | EBG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008578884 | 3008578884 | HARVEST DENTAL PRODUCTS LLC | 905 Columbia St., Brea, CA 92821 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain