Essential Dental Systems, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Essential Dental Systems, Inc.” (first 1984, latest 2023), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 156 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 | 1 | 288 |
| 2013 | 0 | — |
| 2014 | 2 | 134 |
| 2015 | 0 | — |
| 2016 | 1 | 157 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 184 |
| 2022 | 0 | — |
| 2023 | 1 | 405 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Essential Dental Systems, Inc. took a median 294 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 4 | 4 |
| KJJ | Cleanser, Root Canal | 3 | 3 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| KIF | Resin, Root Canal Filling | 2 | 2 |
| ECR | Setter, Band, Orthodontic | 1 | 1 |
| EFT | Cleanser, Denture, Over The Counter | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| ELR | Post, Root Canal | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
Review panels
- Dental (18)
Most recent Essential Dental Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223340 | EDS Calculus Softener TURBO CR | ELC | 2023-12-11 | 405 |
| K202281 | EDS Bioceramic Sealer (Bioseal) | KIF | 2021-02-12 | 184 |
| K152691 | EDS Universal Cement | EMA | 2016-02-25 | 157 |
| K140846 | EDS COMBO-RINSE | KJJ | 2014-07-25 | 113 |
| K132609 | EDS ULTRASONIC TIPS | ELC | 2014-01-22 | 155 |
| K111541 | ENDO-EXPRESS (R) HANDPIECE | EGS | 2012-03-16 | 288 |
| K101504 | TI-CORE FLOW | EMA | 2010-10-29 | 150 |
| K072555 | EDTA PLUS | KJJ | 2007-12-13 | 94 |
| K070401 | ENDO-CHX | KJJ | 2007-07-11 | 149 |
| K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | KIF | 2007-02-06 | 40 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Essential Dental Systems, 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.
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.
- Essential Dental Systesm, Inc. (1 510(k)s)
- Essential Medical Supply, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Essential Dental Systems, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Essential Dental Systems, Inc.” (first 1984, latest 2023), across 10 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 Essential Dental Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Essential Dental Systems, Inc. is 156 days.
Which FDA product codes appear under Essential Dental Systems, Inc.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 4); KJJ (Cleanser, Root Canal, 3); EBF (Material, Tooth Shade, Resin, 2).
Next steps
- See all 18 Essential Dental Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Essential Dental Systems, 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.