Manufacturer registered with FDA
Essential Dental Systems, Inc.
South Hackensack, NJ, United States. Lists 18 dental device types with FDA across 1 registered establishment, and holds 15 510(k) clearances as applicant.
- Device types listed
- 18
- Brands and models
- 29
- 510(k) clearances
- 151984–2023
- Markets registered in
- 751 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 7 markets
Where regulators' registries name Essential Dental Systems, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Essential Dental Systems, Inc. | 15 clearances | 1984–2023 | Below |
| Canada | Health Canada | Registration holder | ESSENTIAL DENTAL SYSTEMS | 39 | 2000–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Essential Dental SystemsESSENTIAL DENTAL SYSTEMS · Essential Dental Systems, Inc | 6 | 1998–2003 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ESSENTIAL DENTAL SYSTEMS, INC. | 3 | 2005–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | Essential Dental Systems Inc | 1 | 2006–2006 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ESSENTIAL DENTAL SYSTEMS, INC. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Essential Dental Systems | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Essential Dental Systems, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Belixa Injectable, Belixa Bulk FillTi-CoreTi-Core Natural | 2006 |
| Dental CementEMA · Class 2 | Dental cements | Maker | CEMPOWERFlexi-Flow Auto ETi-Core Flow Plus, Ti-Core Auto E | 1992 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | BioSealEZ-Fill Bi-Directional SpiralEZ-Fill CementEZ-Fill Root Canal CementEZ-Fill Xpress | 2007 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Countersink DrillPrimary Reamer, Secondary Drill, Gates Glidden Drill, Peeso Reamer, Pleezer Reamer | 2006 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | C-MOR | 2011 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Lister | Endo CSV LED Light | 2019 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Endo-Express | 2007 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | EDS Depth Gauge | 2017 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | EDS Mixing Tips, OVD Caps | 2017 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | C-MORWrench | 2011 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | Bio-LCB | 2022 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Safesider HF Gutta Percha PointsSafeSiders Gutta Percha Points | 2007 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | Safesider HFSafeSiders | 2001 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Endo CSV Hand Piece | 2019 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Turbo-CR | 2025 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Flexi-Post, Flexi-Overdenture, Flexi-Flange, EDS' AccessPost, EDS AccessPost Overdenture, EZ Fit Translucent | 1990 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | EDS Self Etch Bonding Agent | 2017 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Essential Dental Systems, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Dec 2023 | K223340 | EDS Calculus Softener TURBO CR | ELC Ultrasonic Scaler |
| 12 Feb 2021 | K202281 | EDS Bioceramic Sealer (Bioseal) | KIF Root Canal Filling Resin |
| 25 Feb 2016 | K152691 | EDS Universal Cement | EMA Dental Cement |
| 22 Jan 2014 | K132609 | EDS ULTRASONIC TIPS | ELC Ultrasonic Scaler |
| 16 Mar 2012 | K111541 | ENDO-EXPRESS (R) HANDPIECE | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 29 Oct 2010 | K101504 | TI-CORE FLOW | EMA Dental Cement |
| 6 Feb 2007 | K063856 | EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM | KIF Root Canal Filling Resin |
| 12 Aug 1994 | K943475 | ULTRA HYDROPHILIC ALGINAE | ELW Impression Material |
| 26 Jan 1994 | K922252 | TI-CORE NEW & IMPROVED | EBF Resin Tooth Shade Material |
| 26 Jan 1994 | K922251 | TI-CORE-NATURAL | EBF Resin Tooth Shade Material |
| 26 Jan 1994 | K922250 | FLEXI-FLOW CEMENT WITH TITANIUM | EMA Dental Cement |
| 26 Jan 1994 | K922249 | FLEXI-FLOW CEMENT NATURAL | EMA Dental Cement |
| 13 Jan 1993 | K914257 | DENTURE PRODUCT X | EFT Over the Counter Denture Cleanser |
| 14 Feb 1990 | K896693 | FLEXI-CAST CROWN CORE SYSTEM | ELR Root Canal Post |
| 27 Sep 1984 | K843018 | FLEXI-POST | ECR Orthodontic Band Setter |
Also lists devices cleared under other names
Essential Dental Systems, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Spident Co., Ltd. (3), Dentamerica (1), Mds (1), Wallace A. Erickson & Co. (1), Nsk Nakanishi, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 May 2025 | K250317 | EsFlow PLUS | Spident Co., Ltd. | EBF Resin Tooth Shade Material |
| 19 Dec 2022 | K214076 | EsCem | Spident Co., Ltd. | EMA Dental Cement |
| 11 Jun 2014 | K134022 | BASE IT | Spident Co., Ltd. | EJK Calcium Hydroxide Cavity Liner |
| 7 Jan 2010 | K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | Dentamerica | EKX Ac-Powered Direct Drive Handpiece |
| 18 Jan 2000 | K992727 | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM | Mds | KIF Root Canal Filling Resin |
| 26 Feb 1999 | K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | Wallace A. Erickson & Co. | KLE Resin Tooth Bonding Agent |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ESSENTIAL DENTAL SYSTEMS, INC.FDA reg. 2433629 | S Hackensack, NJ, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2433629). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.