Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Essential Dental Systems, Inc. with 19 510(k) clearances. The most recent is a 510(k) clearance dated Dec 11, 2023: EDS Calculus Softener TURBO CR.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 11, 2023 | EDS Calculus Softener TURBO CRK223340 · ELC | 510(k) clearances |
| Feb 12, 2021 | EDS Bioceramic Sealer (Bioseal)K202281 · KIF | 510(k) clearances |
| Feb 25, 2016 | EDS Universal CementK152691 · EMA | 510(k) clearances |
| Feb 25, 2015 | Irritrol, EDS Combo-RinseK150020 · KJJ | 510(k) clearances |
| Jul 25, 2014 | EDS COMBO-RINSEK140846 · KJJ | 510(k) clearances |
| Jan 22, 2014 | EDS ULTRASONIC TIPSK132609 · ELC | 510(k) clearances |
| Mar 16, 2012 | ENDO-EXPRESS (R) HANDPIECEK111541 · EGS | 510(k) clearances |
| Oct 29, 2010 | TI-CORE FLOWK101504 · EMA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
