Harvest Dental Products, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Harvest Dental Products, LLC” (first 2014, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 248 days. Since 2017 the median was 258 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 245 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 282 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 248 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Harvest Dental Products, LLC took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (5)
Most recent Harvest Dental Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231389 | Harvest Dental HD Gum Strip | EBI | 2023-08-16 | 96 |
| K222961 | Harvest Conceal ZR Block Out | EIH | 2023-06-02 | 248 |
| K222489 | Harvest Printable Resin | EBI | 2023-05-12 | 268 |
| K180578 | Harvest Dental Polymer Blocks | EBG | 2018-12-12 | 282 |
| K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | EBG | 2014-05-21 | 245 |
Recalls
openFDA lists no recalls under a recalling firm named Harvest Dental Products, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Harvest Technologies, Corp. (9 510(k)s)
- Harvest Intl. of America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Harvest Dental Products, LLC?
FDA lists 5 510(k) clearances under the applicant name “Harvest Dental Products, LLC” (first 2014, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Harvest Dental Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harvest Dental Products, LLC is 248 days. Since 2017: 258 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Harvest Dental Products, LLC?
The most frequent FDA product codes under this applicant name are EBG (Crown And Bridge, Temporary, Resin, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2); EIH (Powder, Porcelain, 1).
Next steps
- See all 5 Harvest Dental Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code EBG, Harvest Dental Products, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.