Jedental Co., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Jedental Co., Inc.” (first 1993, latest 1994), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EAY | Light, Fiber Optic, Dental | 1 | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
Review panels
- Dental (8)
Most recent Jedental Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933612 | JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) | EMA | 1994-02-24 | 220 |
| K935718 | JEDENTAL VLC DENTAL CURING LIGHT | EAY | 1994-01-26 | 57 |
| K934073 | JEDENTAL GLASS IONOMER CEMENT AND LINER | EMA | 1994-01-26 | 159 |
| K935727 | P&FS PIT AND FISSURE SEALANT | EBC | 1994-01-21 | 51 |
| K933656 | JEDENTAL PSROFILL SELF-CURE COMPOSITE | EBF | 1993-11-17 | 113 |
| K933554 | JEDENTAL ZINC CEMENT IMPROVED | EMA | 1993-11-01 | 103 |
| K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) | EMA | 1993-11-01 | 104 |
| K931880 | PROFILL LC COMPOSITE | EBF | 1993-07-08 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Jedental Co., 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 Jedental Co., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Jedental Co., Inc.” (first 1993, latest 1994), 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 Jedental Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jedental Co., Inc. is 104 days.
Which FDA product codes appear under Jedental Co., Inc.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 4); EBF (Material, Tooth Shade, Resin, 2); EAY (Light, Fiber Optic, Dental, 1).
Next steps
- See all 8 Jedental Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Jedental Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.