Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Essential Dental Systems, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
630 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | 2023-12-11 | 405 | 0 |
| K152691 | EDS Universal Cement | Essential Dental Systems, Inc. | 2016-02-25 | 157 | 0 |
| K140846 | EDS COMBO-RINSE | Essential Dental Systems, Inc. | 2014-07-25 | 113 | 0 |
| K132609 | EDS ULTRASONIC TIPS | Essential Dental Systems, Inc. | 2014-01-22 | 155 | 0 |
| K111541 | ENDO-EXPRESS (R) HANDPIECE | Essential Dental Systems, Inc. | 2012-03-16 | 288 | 0 |
| K101504 | TI-CORE FLOW | Essential Dental Systems, Inc. | 2010-10-29 | 150 | 0 |
| K072555 | EDTA PLUS | Essential Dental Systems, Inc. | 2007-12-13 | 94 | 0 |
| K070401 | ENDO-CHX | Essential Dental Systems, Inc. | 2007-07-11 | 149 | 0 |
| K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | Essential Dental Systems, Inc. | 2007-02-06 | 40 | 0 |
| K943475 | ULTRA HYDROPHILIC ALGINAE | Essential Dental Systems, Inc. | 1994-08-12 | 24 | 0 |
| K922250 | FLEXI-FLOW CEMENT WITH TITANIUM | Essential Dental Systems, Inc. | 1994-01-26 | 630 | 0 |
| K922251 | TI-CORE-NATURAL | Essential Dental Systems, Inc. | 1994-01-26 | 630 | 0 |
| K922249 | FLEXI-FLOW CEMENT NATURAL | Essential Dental Systems, Inc. | 1994-01-26 | 630 | 0 |
| K922252 | TI-CORE NEW & IMPROVED | Essential Dental Systems, Inc. | 1994-01-26 | 630 | 0 |
| K914257 | DENTURE PRODUCT X | Essential Dental Systems, Inc. | 1993-01-13 | 478 | 0 |
| K896693 | FLEXI-CAST CROWN CORE SYSTEM | Essential Dental Systems, Inc. | 1990-02-14 | 78 | 0 |
| K843018 | FLEXI-POST | Essential Dental Systems, Inc. | 1984-09-27 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda