Parkell, Inc.: FDA filings under this applicant name
FDA lists 61 510(k) clearances under the applicant name “Parkell, Inc.” (first 1976, latest 2025), across 21 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 180 days, against 132 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 | 106 |
| 2013 | 0 | — |
| 2014 | 1 | 351 |
| 2015 | 2 | 126 |
| 2016 | 0 | — |
| 2017 | 1 | 125 |
| 2018 | 1 | 112 |
| 2019 | 2 | 180 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 353 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 297 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Parkell, Inc. took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 16 | 16 |
| EMA | Cement, Dental | 8 | 8 |
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| ELC | Scaler, Ultrasonic | 4 | 4 |
| EAT | Tester, Pulp | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 3 | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 | 3 |
| ELW | Material, Impression | 3 | 3 |
| EBD | Coating, Filling Material, Resin | 2 | 2 |
| LQY | Locator, Root Apex | 2 | 2 |
Plus 11 more product codes.
Review panels
- Dental (61)
Most recent Parkell, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243254 | Parkell Pit and Fissure Sealant | EBC | 2025-08-08 | 297 |
| K210259 | Parkell Self-Adhesive Cement | EMA | 2022-01-20 | 353 |
| K191103 | Parkell Desensitizer Gel | EJK | 2019-11-22 | 211 |
| K190930 | SmarTemp X1 | EBG | 2019-09-05 | 148 |
| K182296 | HyperFil-LV | EBF | 2018-12-14 | 112 |
| K172176 | Parkell Universal Adhesive | KLE | 2017-11-21 | 125 |
| K151518 | BRUSH&BOND PLUS | KLE | 2015-09-18 | 105 |
| K142848 | EAZY PRIMER | KLE | 2015-02-24 | 147 |
| K132115 | ABSOLUTE DENTIN 2 | EBF | 2014-06-25 | 351 |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | MVL | 2012-04-12 | 106 |
51 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Parkell, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Parkell, Inc.?
FDA lists 61 510(k) clearances under the applicant name “Parkell, Inc.” (first 1976, latest 2025), across 21 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 Parkell, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Parkell, Inc. is 74 days. Since 2017: 180 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Parkell, Inc.?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 16); EMA (Cement, Dental, 8); EBF (Material, Tooth Shade, Resin, 6).
Next steps
- See all 61 Parkell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KLE, Parkell, Inc.'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.