Data / Medical devices / United States / Essential Dental Systems, Inc.
Essential Dental Systems, Inc.: FDA-registered device maker in S Hackensack, NJ, United States, 17 510(k) clearances
Essential Dental Systems, Inc. is registered with the FDA (registration 2433629) in S Hackensack, NJ, United States. It lists 20 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2433629
- Address
- 89 Leuning ST., S Hackensack, NJ, United States, 07606
- Owner or operator
- ESSENTIAL DENTAL SYSTEMS, INC. (2433629)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 7, 1990
- Registered through
- 2027
- Brand names listed
- Belixa Injectable, Belixa Bulk Fill, Bio-LCB, BioSeal, C-MOR, CEMPOWER, Countersink Drill, EDS Depth Gauge, EDS Mixing Tips, OVD Caps and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2025 | K250317 | EsFlow PLUS | EBF | Substantially Equivalent | Spident Co., Ltd. | accessdata.fda.gov |
| December 11, 2023 | K223340 | EDS Calculus Softener TURBO CR | ELC | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| December 19, 2022 | K214076 | EsCem | EMA | Substantially Equivalent | Spident Co., Ltd. | accessdata.fda.gov |
| February 12, 2021 | K202281 | EDS Bioceramic Sealer (Bioseal) | KIF | Substantially Equivalent | Essential Dental Systems | accessdata.fda.gov |
| February 25, 2015 | K150020 | Irritrol, EDS Combo-Rinse | KJJ | Substantially Equivalent | Essential Dental Systesm, Inc. | accessdata.fda.gov |
| June 11, 2014 | K134022 | BASE IT | EJK | Substantially Equivalent | Spident Co., Ltd. | accessdata.fda.gov |
| October 29, 2010 | K101504 | TI-CORE FLOW | EMA | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| January 7, 2010 | K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | EKX | Substantially Equivalent | Dentamerica | accessdata.fda.gov |
| December 13, 2007 | K072555 | EDTA PLUS | KJJ | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| July 11, 2007 | K070401 | ENDO-CHX | KJJ | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| February 6, 2007 | K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | KIF | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| January 18, 2000 | K992727 | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM | KIF | Substantially Equivalent | Mds | accessdata.fda.gov |
| February 26, 1999 | K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | KLE | Substantially Equivalent | Wallace A. Erickson & Co. | accessdata.fda.gov |
| September 12, 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | EGS | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| January 26, 1994 | K922252 | TI-CORE NEW & IMPROVED | EBF | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| January 26, 1994 | K922251 | TI-CORE-NATURAL | EBF | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
| January 26, 1994 | K922249 | FLEXI-FLOW CEMENT NATURAL | EMA | Substantially Equivalent | Essential Dental Systems, Inc. | accessdata.fda.gov |
Compare with other makers
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Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.