Company ยท US
Essential Dental Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2023. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EMA | Cement, Dental | 4 |
| KJJ | Cleanser, Root Canal | 3 |
| EBF | Material, Tooth Shade, Resin | 2 |
| ELC | Scaler, Ultrasonic | 2 |
| KIF | Resin, Root Canal Filling | 2 |
| ECR | Setter, Band, Orthodontic | 1 |
| EFT | Cleanser, Denture, Over The Counter | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| ELR | Post, Root Canal | 1 |
| ELW | Material, Impression | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2023 | K223340 | EDS Calculus Softener TURBO CR Essential Dental Systems, Inc. | ELC |
| Feb 12, 2021 | K202281 | EDS Bioceramic Sealer (Bioseal) Essential Dental Systems | KIF |
| Feb 25, 2016 | K152691 | EDS Universal Cement Essential Dental Systems, Inc. | EMA |
| Jul 25, 2014 | K140846 | EDS COMBO-RINSE Essential Dental Systems, Inc. | KJJ |
| Jan 22, 2014 | K132609 | EDS ULTRASONIC TIPS Essential Dental Systems, Inc. | ELC |
| Mar 16, 2012 | K111541 | ENDO-EXPRESS (R) HANDPIECE Essential Dental Systems, Inc. | EGS |
| Oct 29, 2010 | K101504 | TI-CORE FLOW Essential Dental Systems, Inc. | EMA |
| Dec 13, 2007 | K072555 | EDTA PLUS Essential Dental Systems, Inc. | KJJ |
| Jul 11, 2007 | K070401 | ENDO-CHX Essential Dental Systems, Inc. | KJJ |
| Feb 6, 2007 | K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM Essential Dental Systems, Inc. | KIF |
| Aug 12, 1994 | K943475 | ULTRA HYDROPHILIC ALGINAE Essential Dental Systems, Inc. | ELW |
| Jan 26, 1994 | K922252 | TI-CORE NEW & IMPROVED Essential Dental Systems, Inc. | EBF |
| Jan 26, 1994 | K922251 | TI-CORE-NATURAL Essential Dental Systems, Inc. | EBF |
| Jan 26, 1994 | K922250 | FLEXI-FLOW CEMENT WITH TITANIUM Essential Dental Systems, Inc. | EMA |
| Jan 26, 1994 | K922249 | FLEXI-FLOW CEMENT NATURAL Essential Dental Systems, Inc. | EMA |
| Jan 13, 1993 | K914257 | DENTURE PRODUCT X Essential Dental Systems, Inc. | EFT |
| Feb 14, 1990 | K896693 | FLEXI-CAST CROWN CORE SYSTEM Essential Dental Systems, Inc. | ELR |
| Sep 27, 1984 | K843018 | FLEXI-POST Essential Dental Systems, Inc. | ECR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||