Park Dental Research Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Park Dental Research Corp.” (first 1986, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 113 days. Since 2017 the median was 136 days, against 184 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 |
|---|---|---|
| 2012 | 1 | 105 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 158 |
| 2019 | 1 | 301 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 113 |
| 2025 | 1 | 92 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Park Dental Research Corp. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 3 | 3 |
| NXC | Aligner, Sequential | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| LRK | Device, Anti-Snoring | 1 | 1 |
Review panels
- Dental (7)
Most recent Park Dental Research Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252976 | Park Dental Nylon MAD | LRK | 2025-12-18 | 92 |
| K233935 | DigiLine Direct Print Aligner System | NXC | 2024-04-05 | 113 |
| K180648 | Park Dental Research Aligners | NXC | 2019-01-08 | 301 |
| K181220 | Juell 3D Volo Base | EBI | 2018-10-12 | 158 |
| K121707 | LEW MDI O-BALL COLLARED IMPLANT, | DZE | 2012-09-24 | 105 |
| K082800 | STAR/VENT INTERNAL HEX SCREW IMPLANT | DZE | 2010-08-26 | 701 |
| K854749 | STARTANIUS DENTAL IMPLANT SYSTEM | DZE | 1986-03-06 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Park Dental Research Corp..
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.
- Park Medical Systems, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Park Dental Research Corp.?
FDA lists 7 510(k) clearances under the applicant name “Park Dental Research Corp.” (first 1986, latest 2025), across 4 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 Park Dental Research Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Park Dental Research Corp. is 113 days. Since 2017: 136 days, versus 184 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Park Dental Research Corp.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 3); NXC (Aligner, Sequential, 2); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Next steps
- See all 7 Park Dental Research Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Park Dental Research Corp.'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.